Type 2 Diabetes Mellitus
Conditions
Brief summary
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.
Interventions
DRUGSaxagliptin
Tablets, Oral, 2.5 mg, once daily, 12 weeks
DRUGPlacebo
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes who are drug-naive * Screening HbA1c ≥ 6.8% and ≤ 9.7% * Screening fasting or random C-peptide \> 0.5 ng/mL * \< 35 years old must be negative for anti-GAD antibodies * Body Mass Index \< 35 kg/m2
Exclusion criteria
* Symptoms of poorly controlled diabetes * History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening * Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis * Significant cardiovascular history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent. |
| Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal. |
| Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. |
| Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. |
| Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. |
| Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. |
| Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. |
| Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort |
| Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. |
| Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown. |
| Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown. |
| Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | Baseline, Week 6 | Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown. |
| Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown. |
| Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement). |
| Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | Baseline, Week 12 | Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement). |
| Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 14 | Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort. |
| Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 10, Week 16 | Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort. |
| Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 8, Week 14 | Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort. |
| Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 10, Week 16 | Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort. |
| Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 8, Week 14 | Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort. |
| Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 10, Week 16 | Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort. |
| Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | Baseline, Week 6 | Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C \<7%, ≥7% to \<8%, ≥8% to \<9%, and ≥9% in the 0 & 100 mg cohort. |
| Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | Baseline, Week 6 | Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG \<140 mg/dL, ≥140 mg/dL to \<180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort. |
| Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
| Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort | Week 6 | Percentage of participants achieving A1C \< 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. |
| Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort | Baseline, Week 6 | Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.) |
| Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort | Baseline, Week 6 | Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.) |
| Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control | Week 4, Week 6 | Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.) |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | Baseline, Week 6 | Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose \<140 mg/dL, ≥140 to \<200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort. |
| Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | Baseline, Week 6 | Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | 55 |
| Saxagliptin 5 mg (0-40 mg Cohort) | 47 |
| Saxagliptin 10 mg (0-40 mg Cohort) | 63 |
| Saxagliptin 20 mg (0-40 mg Cohort) | 54 |
| Saxagliptin 40 mg (0-40 mg Cohort) | 52 |
| Placebo (0-40 mg Cohort) | 67 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | 44 |
| Placebo (0 & 100 mg Cohort) | 41 |
| Total | 423 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Period | Administrative reason by sponsor | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Double-Blind Treatment Period | Adverse Event | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Treatment Period | Lack of Efficacy | 2 | 5 | 5 | 7 | 3 | 6 | 0 | 1 | 0 | 0 |
| Double-Blind Treatment Period | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 0 | 0 |
| Double-Blind Treatment Period | Poor/Noncompliance | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Double-Blind Treatment Period | Subject no longer meets study criteria | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Double-Blind Treatment Period | Subject Withdrew consent | 4 | 3 | 3 | 1 | 1 | 2 | 0 | 3 | 0 | 0 |
| Follow-Up Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow-Up Period | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Follow-Up Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 |
| Follow-Up Period | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow-Up Period | Poor/Noncompliance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow-Up Period | Subject withdrew Consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Saxagliptin 2.5 mg (0-40 mg Cohort) | Saxagliptin 5 mg (0-40 mg Cohort) | Saxagliptin 10 mg (0-40 mg Cohort) | Saxagliptin 20 mg (0-40 mg Cohort) | Saxagliptin 40 mg (0-40 mg Cohort) | Placebo (0-40 mg Cohort) | Saxagliptin 100 mg (0 & 100 mg Cohort) | Placebo (0 & 100 mg Cohort) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <65 years | 50 participants | 39 participants | 54 participants | 50 participants | 41 participants | 55 participants | 38 participants | 35 participants | 362 participants |
| Age, Customized >= 65 years | 5 participants | 8 participants | 9 participants | 4 participants | 11 participants | 12 participants | 6 participants | 6 participants | 61 participants |
| Sex: Female, Male Female | 33 Participants | 22 Participants | 23 Participants | 16 Participants | 22 Participants | 25 Participants | 17 Participants | 18 Participants | 176 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 40 Participants | 38 Participants | 30 Participants | 42 Participants | 27 Participants | 23 Participants | 247 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 63 | 16 / 44 | 35 / 55 | 33 / 54 | 27 / 52 | 23 / 47 | 17 / 41 | 38 / 67 |
| serious Total, serious adverse events | 1 / 63 | 0 / 44 | 1 / 55 | 2 / 54 | 0 / 52 | 0 / 47 | 0 / 41 | 2 / 67 |
Outcome results
Primary
Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.67 percentage of glycosylated hemoglobins | Standard Deviation 0.8 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.95 percentage of glycosylated hemoglobins | Standard Deviation 0.97 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.81 percentage of glycosylated hemoglobins | Standard Deviation 0.91 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.74 percentage of glycosylated hemoglobins | Standard Deviation 0.93 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.78 percentage of glycosylated hemoglobins | Standard Deviation 1.04 |
| Placebo (0-40 mg Cohort) | Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort | -0.29 percentage of glycosylated hemoglobins | Standard Deviation 0.82 |
Comparison: A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.p-value: 0.9888Kruskal-Wallis
Primary
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.72 percentage of glycosylated hemoglobins | Standard Error 0.12 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.90 percentage of glycosylated hemoglobins | Standard Error 0.14 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.81 percentage of glycosylated hemoglobins | Standard Error 0.11 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.74 percentage of glycosylated hemoglobins | Standard Error 0.12 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.80 percentage of glycosylated hemoglobins | Standard Error 0.12 |
| Placebo (0-40 mg Cohort) | Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort | -0.27 percentage of glycosylated hemoglobins | Standard Error 0.11 |
p-value: 0.9888ANCOVA
Secondary
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.50 units on a scale | Standard Deviation 2.03 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | -0.19 units on a scale | Standard Deviation 1.77 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | -0.13 units on a scale | Standard Deviation 1.91 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | -0.34 units on a scale | Standard Deviation 1.21 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.22 units on a scale | Standard Deviation 1.54 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | -0.05 units on a scale | Standard Deviation 1.38 |
Secondary
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.38 units on a scale | Standard Deviation 2.04 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.31 units on a scale | Standard Deviation 2.41 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.45 units on a scale | Standard Deviation 1.88 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.22 units on a scale | Standard Deviation 1.22 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.04 units on a scale | Standard Deviation 2 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.22 units on a scale | Standard Deviation 1.8 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.25 units on a scale | Standard Deviation 4.52 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.63 units on a scale | Standard Deviation 2.77 |
Secondary
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.02 ng/mL | Standard Error 0.23 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.11 ng/mL | Standard Error 0.28 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.12 ng/mL | Standard Error 0.21 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.02 ng/mL | Standard Error 0.23 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.27 ng/mL | Standard Error 0.23 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.07 ng/mL | Standard Error 0.2 |
Secondary
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.03 ng/mL | Standard Error 0.17 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.09 ng/mL | Standard Error 0.19 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.12 ng/mL | Standard Error 0.16 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.17 ng/mL | Standard Error 0.17 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.14 ng/mL | Standard Error 0.17 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.13 ng/mL | Standard Error 0.15 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.27 ng/mL | Standard Error 0.17 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 ng/mL | Standard Error 0.18 |
Secondary
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.23 ng/mL | Standard Error 0.16 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.42 ng/mL | Standard Error 0.2 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.02 ng/mL | Standard Error 0.15 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.02 ng/mL | Standard Error 0.17 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | -0.04 ng/mL | Standard Error 0.16 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.21 ng/mL | Standard Error 0.15 |
Secondary
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.29 ng/mL | Standard Error 0.14 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.08 ng/mL | Standard Error 0.16 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.10 ng/mL | Standard Error 0.13 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.08 ng/mL | Standard Error 0.14 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 ng/mL | Standard Error 0.14 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 ng/mL | Standard Error 0.13 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 ng/mL | Standard Error 0.15 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.17 ng/mL | Standard Error 0.16 |
Secondary
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -14.89 mg/dL | Standard Error 4.78 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -16.45 mg/dL | Standard Error 5.58 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -19.57 mg/dL | Standard Error 4.35 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -18.70 mg/dL | Standard Error 4.94 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -20.75 mg/dL | Standard Error 4.77 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | 0.77 mg/dL | Standard Error 4.27 |
Secondary
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -15.24 mg/dL | Standard Error 5.22 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -16.53 mg/dL | Standard Error 5.75 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -16.78 mg/dL | Standard Error 4.72 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -14.35 mg/dL | Standard Error 4.92 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -26.03 mg/dL | Standard Error 5.38 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -9.30 mg/dL | Standard Error 4.76 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -25.99 mg/dL | Standard Error 4.3 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.80 mg/dL | Standard Error 4.61 |
Secondary
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -1.20 mg/dL | Standard Error 2.68 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 0.02 mg/dL | Standard Error 3.13 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 1.63 mg/dL | Standard Error 2.47 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 3.14 mg/dL | Standard Error 2.82 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -0.14 mg/dL | Standard Error 2.68 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 1.89 mg/dL | Standard Error 2.36 |
Secondary
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.42 mg/dL | Standard Error 2.54 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.23 mg/dL | Standard Error 2.82 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.15 mg/dL | Standard Error 2.36 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 3.48 mg/dL | Standard Error 2.64 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.95 mg/dL | Standard Error 2.65 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -2.37 mg/dL | Standard Error 2.3 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.12 mg/dL | Standard Error 2.35 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.02 mg/dL | Standard Error 2.52 |
Secondary
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 2.93 uU/mL | Standard Error 3.67 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 5.79 uU/mL | Standard Error 4.49 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 2.87 uU/mL | Standard Error 3.37 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 6.81 uU/mL | Standard Error 3.74 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | -1.48 uU/mL | Standard Error 3.65 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 4.70 uU/mL | Standard Error 3.17 |
Secondary
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 5.36 uU/mL | Standard Error 2.74 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.22 uU/mL | Standard Error 3.02 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.47 uU/mL | Standard Error 2.53 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 3.11 uU/mL | Standard Error 2.66 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.60 uU/mL | Standard Error 2.77 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.60 uU/mL | Standard Error 2.44 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.72 uU/mL | Standard Error 3.07 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.63 uU/mL | Standard Error 3.25 |
Secondary
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 2.33 uU/mL | Standard Error 3.08 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 5.26 uU/mL | Standard Error 3.76 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 1.98 uU/mL | Standard Error 2.85 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 3.56 uU/mL | Standard Error 3.14 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | -1.49 uU/mL | Standard Error 3.05 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 4.42 uU/mL | Standard Error 2.71 |
Secondary
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 5.58 uU/mL | Standard Error 2.53 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.04 uU/mL | Standard Error 2.75 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.85 uU/mL | Standard Error 2.32 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.18 uU/mL | Standard Error 2.47 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.11 uU/mL | Standard Error 2.52 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.28 uU/mL | Standard Error 2.24 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.19 uU/mL | Standard Error 2.62 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.67 uU/mL | Standard Error 2.78 |
Secondary
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.15 units on a scale | Standard Deviation 0.99 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.84 units on a scale | Standard Deviation 2.31 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.35 units on a scale | Standard Deviation 0.97 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | -0.05 units on a scale | Standard Deviation 0.5 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.25 units on a scale | Standard Deviation 0.58 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort | 0.11 units on a scale | Standard Deviation 0.44 |
Secondary
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.44 units on a scale | Standard Deviation 1.06 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.37 units on a scale | Standard Deviation 0.76 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.31 units on a scale | Standard Deviation 0.77 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.18 units on a scale | Standard Deviation 0.81 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.71 units on a scale | Standard Deviation 3.71 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.04 units on a scale | Standard Deviation 0.72 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | 0.46 units on a scale | Standard Deviation 1.17 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts. | -0.05 units on a scale | Standard Deviation 0.83 |
Secondary
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.17 ng/mL | Standard Error 0.23 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.27 ng/mL | Standard Error 0.29 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.05 ng/mL | Standard Error 0.22 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.19 ng/mL | Standard Error 0.24 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.12 ng/mL | Standard Error 0.23 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.14 ng/mL | Standard Error 0.2 |
Secondary
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.13 ng/mL | Standard Error 0.2 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.16 ng/mL | Standard Error 0.23 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.01 ng/mL | Standard Error 0.19 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.06 ng/mL | Standard Error 0.2 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.02 ng/mL | Standard Error 0.21 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.03 ng/mL | Standard Error 0.18 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.35 ng/mL | Standard Error 0.21 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.05 ng/mL | Standard Error 0.22 |
Secondary
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.05 ng/mL | Standard Error 0.2 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.58 ng/mL | Standard Error 0.24 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.16 ng/mL | Standard Error 0.18 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.28 ng/mL | Standard Error 0.2 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.32 ng/mL | Standard Error 0.19 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | -0.08 ng/mL | Standard Error 0.17 |
Secondary
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.35 ng/mL | Standard Error 0.18 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.11 ng/mL | Standard Error 0.2 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.23 ng/mL | Standard Error 0.17 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.07 ng/mL | Standard Error 0.18 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.12 ng/mL | Standard Error 0.18 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.09 ng/mL | Standard Error 0.16 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.00 ng/mL | Standard Error 0.2 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.31 ng/mL | Standard Error 0.21 |
Secondary
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | 0.01 mEg/L | Standard Error 0.03 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | -0.00 mEg/L | Standard Error 0.03 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | -0.06 mEg/L | Standard Error 0.03 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | -0.05 mEg/L | Standard Error 0.03 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | -0.04 mEg/L | Standard Error 0.03 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort | -0.00 mEg/L | Standard Error 0.03 |
Secondary
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | -0.01 mEq/mL | Standard Error 0.02 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | -0.04 mEq/mL | Standard Error 0.03 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | 0.02 mEq/mL | Standard Error 0.02 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | -0.01 mEq/mL | Standard Error 0.02 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | 0.03 mEq/mL | Standard Error 0.02 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort | -0.04 mEq/mL | Standard Error 0.02 |
Secondary
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.02 mEq/mL | Standard Error 0.02 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 mEq/mL | Standard Error 0.02 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.02 mEq/mL | Standard Error 0.02 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.00 mEq/mL | Standard Error 0.02 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.02 mEq/mL | Standard Error 0.02 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.01 mEq/mL | Standard Error 0.02 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.07 mEq/mL | Standard Error 0.02 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.12 mEq/mL | Standard Error 0.03 |
Secondary
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.01 mEg/L | Standard Error 0.03 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.03 mEg/L | Standard Error 0.03 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.07 mEg/L | Standard Error 0.02 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.08 mEg/L | Standard Error 0.03 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.05 mEg/L | Standard Error 0.03 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.02 mEg/L | Standard Error 0.02 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.17 mEg/L | Standard Error 0.02 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.16 mEg/L | Standard Error 0.02 |
Secondary
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -8.39 pg/mL | Standard Error 4.12 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -6.06 pg/mL | Standard Error 5.57 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -12.64 pg/mL | Standard Error 4.3 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -17.21 pg/mL | Standard Error 4.76 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -11.90 pg/mL | Standard Error 4.41 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort | -3.64 pg/mL | Standard Error 3.98 |
Secondary
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -11.84 pg/mL | Standard Error 4.11 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -10.92 pg/mL | Standard Error 4.93 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -11.26 pg/mL | Standard Error 3.99 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.81 pg/mL | Standard Error 4.56 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -9.04 pg/mL | Standard Error 4.21 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.98 pg/mL | Standard Error 3.82 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -14.97 pg/mL | Standard Error 3.69 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.17 pg/mL | Standard Error 3.75 |
Secondary
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | -5.96 pg/mL | Standard Error 3.29 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | -4.46 pg/mL | Standard Error 4.47 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | -6.80 pg/mL | Standard Error 3.42 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | -10.36 pg/mL | Standard Error 3.74 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | -8.56 pg/mL | Standard Error 3.47 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort | 4.53 pg/mL | Standard Error 3.17 |
Secondary
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.94 pg/mL | Standard Error 3.64 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.75 pg/mL | Standard Error 4.42 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -10.39 pg/mL | Standard Error 3.6 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -3.94 pg/mL | Standard Error 4.02 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.99 pg/mL | Standard Error 3.76 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 3.58 pg/mL | Standard Error 3.45 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -8.54 pg/mL | Standard Error 3.87 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.52 pg/mL | Standard Error 4.07 |
Secondary
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -19.79 mg/dL | Standard Error 5.35 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -24.04 mg/dL | Standard Error 6.21 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -28.59 mg/dL | Standard Error 4.92 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -23.56 mg/dL | Standard Error 5.52 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -20.42 mg/dL | Standard Error 5.25 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -2.08 mg/dL | Standard Error 4.76 |
Secondary
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -23.45 mg/dL | Standard Error 6.09 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -29.31 mg/dL | Standard Error 6.8 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -25.32 mg/dL | Standard Error 5.52 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -23.93 mg/dL | Standard Error 5.74 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -30.60 mg/dL | Standard Error 6.12 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -7.81 mg/dL | Standard Error 5.57 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -36.33 mg/dL | Standard Error 4.99 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -10.94 mg/dL | Standard Error 5.42 |
Secondary
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -5.99 mg/dL | Standard Error 3.26 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -5.24 mg/dL | Standard Error 3.82 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -5.69 mg/dL | Standard Error 3.06 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -0.73 mg/dL | Standard Error 3.4 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -0.12 mg/dL | Standard Error 3.22 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 0.79 mg/dL | Standard Error 2.87 |
Secondary
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -7.39 mg/dL | Standard Error 3.24 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -15.91 mg/dL | Standard Error 3.64 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.92 mg/dL | Standard Error 3.05 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.68 mg/dL | Standard Error 3.34 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.89 mg/dL | Standard Error 3.3 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -2.40 mg/dL | Standard Error 2.92 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -12.76 mg/dL | Standard Error 3.87 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.79 mg/dL | Standard Error 4.22 |
Secondary
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 0.98 uU/mL | Standard Error 4.09 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 10.71 uU/mL | Standard Error 5.01 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 2.48 uU/mL | Standard Error 3.79 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 5.90 uU/mL | Standard Error 4.16 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 6.14 uU/mL | Standard Error 4.04 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 1.19 uU/mL | Standard Error 3.54 |
Secondary
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 5.20 uU/mL | Standard Error 3.39 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 8.51 uU/mL | Standard Error 3.81 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.04 uU/mL | Standard Error 3.18 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.10 uU/mL | Standard Error 3.35 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.33 uU/mL | Standard Error 3.4 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.82 uU/mL | Standard Error 3.04 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -4.44 uU/mL | Standard Error 3.3 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 7.69 uU/mL | Standard Error 3.54 |
Secondary
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | -0.23 uU/mL | Standard Error 3.47 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 10.17 uU/mL | Standard Error 4.25 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 1.43 uU/mL | Standard Error 3.25 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 3.35 uU/mL | Standard Error 3.53 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 5.36 uU/mL | Standard Error 3.44 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | -0.70 uU/mL | Standard Error 3.06 |
Secondary
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.95 uU/mL | Standard Error 3.25 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 5.07 uU/mL | Standard Error 3.61 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.40 uU/mL | Standard Error 3.05 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.89 uU/mL | Standard Error 3.24 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.13 uU/mL | Standard Error 3.23 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 3.23 uU/mL | Standard Error 2.91 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.22 uU/mL | Standard Error 3.05 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 9.87 uU/mL | Standard Error 3.27 |
Secondary
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.08 ng/mL | Standard Error 0.26 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.18 ng/mL | Standard Error 0.31 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | -0.02 ng/mL | Standard Error 0.23 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.22 ng/mL | Standard Error 0.26 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.01 ng/mL | Standard Error 0.26 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort | 0.22 ng/mL | Standard Error 0.23 |
Secondary
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.06 ng/mL | Standard Error 0.22 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.36 ng/mL | Standard Error 0.25 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.16 ng/mL | Standard Error 0.21 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.20 ng/mL | Standard Error 0.22 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.19 ng/mL | Standard Error 0.22 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.24 ng/mL | Standard Error 0.2 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.33 ng/mL | Standard Error 0.25 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.10 ng/mL | Standard Error 0.26 |
Secondary
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.29 ng/mL | Standard Error 0.22 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.59 ng/mL | Standard Error 0.27 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.16 ng/mL | Standard Error 0.2 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.27 ng/mL | Standard Error 0.22 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.20 ng/mL | Standard Error 0.22 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort | 0.13 ng/mL | Standard Error 0.2 |
Secondary
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.27 ng/mL | Standard Error 0.2 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.35 ng/mL | Standard Error 0.22 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.17 ng/mL | Standard Error 0.19 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.12 ng/mL | Standard Error 0.2 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.36 ng/mL | Standard Error 0.2 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.17 ng/mL | Standard Error 0.18 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.04 ng/mL | Standard Error 0.21 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.20 ng/mL | Standard Error 0.21 |
Secondary
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
Secondary
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)
Time frame: Baseline, Week 6
Secondary
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -24.42 mg/dL | Standard Error 6.73 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -35.30 mg/dL | Standard Error 7.84 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -41.04 mg/dL | Standard Error 6.14 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -27.54 mg/dL | Standard Error 6.97 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -33.98 mg/dL | Standard Error 6.71 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort | -1.41 mg/dL | Standard Error 6.08 |
Secondary
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose \<140 mg/dL, ≥140 to \<200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | <140 mg/dL (n=1; n=3) | -18.00 mg/dL | Standard Deviation 0 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | ≥140 to <200 mg/dL (n=17; n=12) | -24.29 mg/dL | Standard Deviation 21.44 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | ≥200 mg/dL (n=20; n=20) | -62.10 mg/dL | Standard Deviation 34.83 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | <140 mg/dL (n=1; n=3) | 11.33 mg/dL | Standard Deviation 12.1 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | ≥140 to <200 mg/dL (n=17; n=12) | -19.25 mg/dL | Standard Deviation 25.3 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort | ≥200 mg/dL (n=20; n=20) | -21.35 mg/dL | Standard Deviation 57.1 |
Secondary
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -28.45 mg/dL | Standard Error 6.85 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -39.99 mg/dL | Standard Error 7.8 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -27.51 mg/dL | Standard Error 6.21 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -24.32 mg/dL | Standard Error 6.48 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -34.44 mg/dL | Standard Error 6.9 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -4.96 mg/dL | Standard Error 6.29 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -44.58 mg/dL | Standard Error 5.65 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -17.22 mg/dL | Standard Error 5.88 |
Secondary
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -9.29 mg/dL | Standard Error 4.26 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -16.51 mg/dL | Standard Error 5.01 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -19.44 mg/dL | Standard Error 3.94 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -3.95 mg/dL | Standard Error 4.43 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | -13.83 mg/dL | Standard Error 4.27 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort | 0.30 mg/dL | Standard Error 3.79 |
Secondary
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -10.08 mg/dL | Standard Error 4.01 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -23.94 mg/dL | Standard Error 4.57 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -12.94 mg/dL | Standard Error 3.75 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.10 mg/dL | Standard Error 4.14 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -11.88 mg/dL | Standard Error 4.09 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.31 mg/dL | Standard Error 3.63 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -20.69 mg/dL | Standard Error 4.09 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -8.59 mg/dL | Standard Error 4.32 |
Secondary
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 2.62 uU/mL | Standard Error 4.36 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 4.61 uU/mL | Standard Error 5.31 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 0.38 uU/mL | Standard Error 3.95 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 4.99 uU/mL | Standard Error 4.39 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | 2.42 uU/mL | Standard Error 4.4 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort | -2.22 uU/mL | Standard Error 3.8 |
Secondary
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.35 uU/mL | Standard Error 4.06 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.45 uU/mL | Standard Error 4.49 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.25 uU/mL | Standard Error 3.73 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.75 uU/mL | Standard Error 3.93 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.13 uU/mL | Standard Error 4.11 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 3.33 uU/mL | Standard Error 3.59 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -8.17 uU/mL | Standard Error 4.37 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.83 uU/mL | Standard Error 4.56 |
Secondary
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 2.71 uU/mL | Standard Error 3.97 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 4.85 uU/mL | Standard Error 4.82 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | -0.83 uU/mL | Standard Error 3.63 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 2.02 uU/mL | Standard Error 3.99 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | 1.44 uU/mL | Standard Error 4.01 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort | -3.52 uU/mL | Standard Error 3.51 |
Secondary
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.03 uU/mL | Standard Error 3.93 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.84 uU/mL | Standard Error 4.29 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.75 uU/mL | Standard Error 3.6 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 2.28 uU/mL | Standard Error 3.83 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.16 uU/mL | Standard Error 3.93 |
| Placebo (0-40 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.82 uU/mL | Standard Error 3.47 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -3.61 uU/mL | Standard Error 3.78 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 4.19 uU/mL | Standard Error 3.95 |
Secondary
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 14
Population: Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.55 percentage of glycated hemoglobins | Standard Deviation 0.93 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.84 percentage of glycated hemoglobins | Standard Deviation 1.04 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.78 percentage of glycated hemoglobins | Standard Deviation 0.98 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.66 percentage of glycated hemoglobins | Standard Deviation 1.03 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.69 percentage of glycated hemoglobins | Standard Deviation 1.04 |
| Placebo (0-40 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.25 percentage of glycated hemoglobins | Standard Deviation 0.83 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -1.15 percentage of glycated hemoglobins | Standard Deviation 0.76 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.45 percentage of glycated hemoglobins | Standard Deviation 0.65 |
Secondary
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 10, Week 16
Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.34 percentage of glycated hemoglobins | Standard Deviation 0.98 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.72 percentage of glycated hemoglobins | Standard Deviation 0.96 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.64 percentage of glycated hemoglobins | Standard Deviation 0.99 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.57 percentage of glycated hemoglobins | Standard Deviation 0.94 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.53 percentage of glycated hemoglobins | Standard Deviation 0.97 |
| Placebo (0-40 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.24 percentage of glycated hemoglobins | Standard Deviation 0.87 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -1.01 percentage of glycated hemoglobins | Standard Deviation 0.7 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.43 percentage of glycated hemoglobins | Standard Deviation 0.8 |
Secondary
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C \<7%, ≥7% to \<8%, ≥8% to \<9%, and ≥9% in the 0 & 100 mg cohort.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | <7% (n=8; n=12) | -0.61 percent | Standard Deviation 0.26 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥7% to <8% (n=20; n=8) | -1.01 percent | Standard Deviation 0.41 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥8% to <9% (n=9; n=11) | -1.14 percent | Standard Deviation 0.53 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥9% (n=6; n=4) | -2.10 percent | Standard Deviation 0.88 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥9% (n=6; n=4) | -0.83 percent | Standard Deviation 0.31 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | <7% (n=8; n=12) | -0.18 percent | Standard Deviation 0.27 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥8% to <9% (n=9; n=11) | -0.34 percent | Standard Deviation 0.95 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort | ≥7% to <8% (n=20; n=8) | -0.30 percent | Standard Deviation 0.15 |
Secondary
Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.71 percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.72 percentage of glycosylated hemoglobins | Standard Error 0.1 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.67 percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.68 percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.82 percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Placebo (0-40 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.33 percentage of glycosylated hemoglobins | Standard Error 0.08 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1.09 percentage of glycosylated hemoglobins | Standard Error 0.09 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.36 percentage of glycosylated hemoglobins | Standard Error 0.09 |
Secondary
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | -0.04 ng/mL | Standard Error 0.14 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | -0.13 ng/mL | Standard Error 0.16 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | -0.09 ng/mL | Standard Error 0.13 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | 0.01 ng/mL | Standard Error 0.14 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | -0.02 ng/mL | Standard Error 0.14 |
| Placebo (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort | 0.02 ng/mL | Standard Error 0.13 |
Secondary
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.15 ng/mL | Standard Error 0.12 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.19 ng/mL | Standard Error 0.13 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.06 ng/mL | Standard Error 0.11 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.02 ng/mL | Standard Error 0.12 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.03 ng/mL | Standard Error 0.13 |
| Placebo (0-40 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.08 ng/mL | Standard Error 0.11 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.52 ng/mL | Standard Error 0.12 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.13 ng/mL | Standard Error 0.13 |
Secondary
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -10.71 mg/dL | Standard Error 3.68 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -18.63 mg/dL | Standard Error 3.82 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -16.10 mg/dL | Standard Error 3.32 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -14.66 mg/dL | Standard Error 3.57 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -18.34 mg/dL | Standard Error 3.67 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -6.20 mg/dL | Standard Error 3.26 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -26.33 mg/dL | Standard Error 3.53 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -3.29 mg/dL | Standard Error 3.81 |
Secondary
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 8, Week 14
Population: Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -12.40 umol/L | Standard Deviation 35.18 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -19.78 umol/L | Standard Deviation 33.8 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -12.77 umol/L | Standard Deviation 37.92 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -17.10 umol/L | Standard Deviation 39.36 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -12.81 umol/L | Standard Deviation 32.41 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -7.48 umol/L | Standard Deviation 34.15 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -21.86 umol/L | Standard Deviation 31.39 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -5.97 umol/L | Standard Deviation 23.67 |
Secondary
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 10, Week 16
Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -8.60 umol/L | Standard Deviation 39.61 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -8.02 umol/L | Standard Deviation 37.54 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -11.02 umol/L | Standard Deviation 40.73 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -19.44 umol/L | Standard Deviation 37.39 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -10.14 umol/L | Standard Deviation 31.45 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -7.05 umol/L | Standard Deviation 35.13 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -15.25 umol/L | Standard Deviation 30.78 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -10.00 umol/L | Standard Deviation 24.26 |
Secondary
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -20.89 umol/L | Standard Error 4.64 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -25.23 umol/L | Standard Error 5.14 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -21.31 umol/L | Standard Error 4.36 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -22.30 umol/L | Standard Error 4.64 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -26.30 umol/L | Standard Error 4.82 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort | -8.57 umol/L | Standard Error 4.33 |
Secondary
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -21.02 umol/L | Standard Error 3.91 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -21.87 umol/L | Standard Error 4.29 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -24.72 umol/L | Standard Error 3.65 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -23.96 umol/L | Standard Error 3.88 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -26.03 umol/L | Standard Error 4.07 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -9.26 umol/L | Standard Error 3.62 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -28.03 umol/L | Standard Error 3.74 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.16 umol/L | Standard Error 4.13 |
Secondary
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 8, Week 14
Population: Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -1.93 mg/dL | Standard Deviation 36.86 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -14.03 mg/dL | Standard Deviation 34.62 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -7.58 mg/dL | Standard Deviation 29.35 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -11.17 mg/dL | Standard Deviation 33.97 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -6.02 mg/dL | Standard Deviation 38.4 |
| Placebo (0-40 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.75 mg/dL | Standard Deviation 29.11 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -14.14 mg/dL | Standard Deviation 26.14 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -3.47 mg/dL | Standard Deviation 26.8 |
Secondary
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.
Time frame: Baseline, Week 10, Week 16
Population: Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0\&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -5.82 mg/dL | Standard Deviation 31.6 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -11.55 mg/dL | Standard Deviation 33.73 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -6.65 mg/dL | Standard Deviation 46.36 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -9.05 mg/dL | Standard Deviation 28.62 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -0.91 mg/dL | Standard Deviation 33.94 |
| Placebo (0-40 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -2.04 mg/dL | Standard Deviation 40.19 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -7.82 mg/dL | Standard Deviation 23.88 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts | -5.97 mg/dL | Standard Deviation 21.76 |
Secondary
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | -10.85 mg/dL | Standard Error 4.61 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | -21.68 mg/dL | Standard Error 4.8 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | -15.91 mg/dL | Standard Error 4.16 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | -13.61 mg/dL | Standard Error 4.48 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | -16.36 mg/dL | Standard Error 4.6 |
| Placebo (0-40 mg Cohort) | Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort | 2.81 mg/dL | Standard Error 4.1 |
Secondary
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG \<140 mg/dL, ≥140 mg/dL to \<180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | < 140 mg/dL (n=17; n=17) | -11.12 mg/dL | Standard Deviation 12.51 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | 140 - < 180 mg/dL (n=17; n=14) | -27.00 mg/dL | Standard Deviation 19.47 |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | ≥180 mg/dL (n=9; n=6) | -56.89 mg/dL | Standard Deviation 25.21 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | < 140 mg/dL (n=17; n=17) | 1.29 mg/dL | Standard Deviation 12.95 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | 140 - < 180 mg/dL (n=17; n=14) | 0.07 mg/dL | Standard Deviation 26.78 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort. | ≥180 mg/dL (n=9; n=6) | -19.50 mg/dL | Standard Deviation 48.14 |
Secondary
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 2.38 uU/mL | Standard Error 1.63 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 1.02 uU/mL | Standard Error 1.93 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 1.41 uU/mL | Standard Error 1.54 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 0.76 uU/mL | Standard Error 1.74 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 2.29 uU/mL | Standard Error 1.65 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort | 1.29 uU/mL | Standard Error 1.51 |
Secondary
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.88 uU/mL | Standard Error 1.22 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 1.05 uU/mL | Standard Error 1.26 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.99 uU/mL | Standard Error 1.11 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.17 uU/mL | Standard Error 1.18 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.38 uU/mL | Standard Error 1.23 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.08 uU/mL | Standard Error 1.11 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -2.03 uU/mL | Standard Error 1.09 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.61 uU/mL | Standard Error 1.13 |
Secondary
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | -0.48 units on a scale | Standard Deviation 2.81 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | 0.34 units on a scale | Standard Deviation 1.21 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | 0.27 units on a scale | Standard Deviation 3.9 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | 0.78 units on a scale | Standard Deviation 3.24 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | 0.17 units on a scale | Standard Deviation 3.68 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort | -0.15 units on a scale | Standard Deviation 1.66 |
Secondary
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.36 units on a scale | Standard Deviation 1.36 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.31 units on a scale | Standard Deviation 1.27 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.04 units on a scale | Standard Deviation 2.84 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.31 units on a scale | Standard Deviation 1.76 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.06 units on a scale | Standard Deviation 2.49 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.25 units on a scale | Standard Deviation 1.91 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.86 units on a scale | Standard Deviation 2.86 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.35 units on a scale | Standard Deviation 2.45 |
Secondary
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -8.1 ng*min/mL | Standard Error 11.5 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 4.8 ng*min/mL | Standard Error 14 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1.6 ng*min/mL | Standard Error 10.5 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 7.1 ng*min/mL | Standard Error 11.4 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -3.4 ng*min/mL | Standard Error 11.6 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -4.0 ng*min/mL | Standard Error 10 |
Secondary
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.2 ng*min/mL | Standard Error 9.4 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 7.6 ng*min/mL | Standard Error 10.3 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -5.5 ng*min/mL | Standard Error 8.7 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 5.4 ng*min/mL | Standard Error 9.2 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.2 ng*min/mL | Standard Error 9.5 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -0.8 ng*min/mL | Standard Error 8.3 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -19.7 ng*min/mL | Standard Error 9.8 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 0.8 ng*min/mL | Standard Error 10.1 |
Secondary
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1226 mg*min/dL | Standard Error 318 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1503 mg*min/dL | Standard Error 353 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1312 mg*min/dL | Standard Error 290 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1246 mg*min/dL | Standard Error 320 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -1626 mg*min/dL | Standard Error 324 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -461 mg*min/dL | Standard Error 280 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -2035 mg*min/dL | Standard Error 263 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -664 mg*min/dL | Standard Error 283 |
Secondary
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1121 mg*min/dL | Standard Error 320 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1505 mg*min/dL | Standard Error 369 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1730 mg*min/dL | Standard Error 289 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1377 mg*min/dL | Standard Error 322 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | -1520 mg*min/dL | Standard Error 314 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 174 mg*min/dL | Standard Error 275 |
Secondary
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time frame: Baseline, Week 12
Population: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 61.2 uU*min/mL | Standard Error 179.9 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 283.4 uU*min/mL | Standard Error 218 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 114.2 uU*min/mL | Standard Error 163.6 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 336.8 uU*min/mL | Standard Error 177.7 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 195.6 uU*min/mL | Standard Error 180.7 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort | 30.3 uU*min/mL | Standard Error 155.6 |
Secondary
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Time frame: Baseline, Week 6
Population: Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 234.2 uU*min/mL | Standard Error 149.5 |
| Saxagliptin 5 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 293.2 uU*min/mL | Standard Error 162.3 |
| Saxagliptin 10 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 120.0 uU*min/mL | Standard Error 136.6 |
| Saxagliptin 20 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 165.4 uU*min/mL | Standard Error 145.3 |
| Saxagliptin 40 mg (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 28.8 uU*min/mL | Standard Error 152.4 |
| Placebo (0-40 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 164.6 uU*min/mL | Standard Error 130.5 |
| Saxagliptin 100 mg (0 & 100 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | -296.0 uU*min/mL | Standard Error 160.4 |
| Placebo (0 & 100 mg Cohort) | Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts | 261.9 uU*min/mL | Standard Error 167.7 |
Secondary
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Time frame: Week 4, Week 6
Secondary
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Percentage of participants achieving A1C \< 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.
Time frame: Week 6
Population: Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort | 72 Percentage of Participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort | 49 Percentage of Participants |
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Population: All participants randomized and treated during the double-blind period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one AE | 65.9 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one related AE | 22.7 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one related AE | 12.2 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one AE | 58.5 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort | At least one SAE | 0 Percentage of participants |
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Population: All participants randomized and treated during the double-blind period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 80.0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 14.5 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 1.8 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 76.6 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 23.4 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 2.1 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 77.8 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 1.6 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 22.2 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 1.6 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 25.9 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 1.9 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 1.9 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 87.0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 23.1 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 3.8 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 75.0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one AE | 79.1 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Discontinuations due to AEs | 1.5 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one SAE | 1.5 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | At least one related AE | 23.9 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
Population: All participants treated during the follow-up period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one related SAE | 2.3 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one AE | 31.8 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one AE | 33.3 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one related SAE | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort | At least one SAE | 0 Percentage of participants |
Secondary
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
Population: All participants treated during the follow-up period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 34.0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 4.0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 2.5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 7.1 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 42.9 Percentage of participants |
| Saxagliptin 5 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 37.9 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 3.4 Percentage of participants |
| Saxagliptin 10 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 37.5 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 2.1 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 20 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 12.5 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 42.6 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Saxagliptin 40 mg (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 4.3 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Discontinuations due to AEs | 0 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one related AE | 6.7 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | Deaths | 0 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one SAE | 1.7 Percentage of participants |
| Placebo (0-40 mg Cohort) | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort | At least one AE | 26.7 Percentage of participants |