Diabetes Mellitus
Conditions
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
Brief summary
The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus
Detailed description
There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes. The aim of the current study is to evaluate the efficacy of alogliptin in combination with pioglitazone in subjects who are inadequately controlled on a thiazolidinedione (pioglitazone or rosiglitazone) alone or in combination with metformin or a sulfonylurea. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).
Interventions
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
DRUGPioglitazone
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening. * No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.) * Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2 * Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.) * Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive. * If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator. * Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg. * Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females. * Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal. * Serum creatinine less than or equal to 2.0 mg per dL. * Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid. * Neither pregnant nor lactating. * Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study. * Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. * No major illness or debility that in the investigator's opinion prohibits the subject from completing the study. * Able and willing to provide written informed consent.
Exclusion criteria
* Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week. * History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.) * History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. * History of treated diabetic gastric paresis. * New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study. * History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening * History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. * History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. * History of a psychiatric disorder that will affect the subject's ability to participate in the study. * History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. * History of alcohol or substance abuse within the 2 years prior to Screening. * Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening. * Prior treatment in an investigational study of alogliptin. * Excluded Medications: * Treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. * Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed. Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | Baseline and Week 26. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin (Week 8). | Baseline and Week 8. | The change between the value of insulin collected at week 8 and insulin collected at baseline. |
| Change From Baseline in Insulin (Week 12). | Baseline and Week 12. | The change between the value of insulin collected at week 12 and insulin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 4). | Baseline and Week 4. | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and Week 16. | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline. |
| Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and Week 20. | The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 1). | Baseline and Week 1. | The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 2). | Baseline and Week 2. | The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 4). | Baseline and Week 4. | The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 8). | Baseline and Week 8. | The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 12). | Baseline and Week 12. | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 16). | Baseline and Week 16. | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Proinsulin (Week 20). | Baseline and Week 20. | The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline. |
| Change From Baseline in Fasting Proinsulin (Week 26). | Baseline and Week 26. | The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 20). | Baseline and Week 20. | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. |
| Change From Baseline in Fasting Plasma Glucose (Week 26). | Baseline and Week 26. | The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline. |
| Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL). | 26 Weeks. | The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study. |
| Number of Participants Requiring Rescue. | 26 Weeks. | The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study. |
| Change From Baseline in Fasting Proinsulin (Week 4). | Baseline and Week 4. | The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline. |
| Change From Baseline in Fasting Proinsulin (Week 8). | Baseline and Week 8. | The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline. |
| Change From Baseline in Fasting Proinsulin (Week 12). | Baseline and Week 12. | The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline. |
| Change From Baseline in Fasting Proinsulin (Week 16). | Baseline and Week 16. | The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline. |
| Change From Baseline in Insulin (Week 16). | Baseline and Week 16. | The change between the value of insulin collected at week 16 and insulin collected at baseline. |
| Change From Baseline in Insulin (Week 20). | Baseline and Week 20. | The change between the value of insulin collected at week 20 and insulin collected at baseline. |
| Change From Baseline in Insulin (Week 26). | Baseline and Week 26. | The change between the value of insulin collected at week 26 and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 4). | Baseline and Week 4. | The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 8). | Baseline and Week 8. | The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 12). | Baseline and Week 12. | The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 16). | Baseline and Week 16. | The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 20). | Baseline and Week 20. | The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in Proinsulin/Insulin Ratio (Week 26). | Baseline and Week 26. | The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline. |
| Change From Baseline in C-peptide (Week 4). | Baseline and Week 4. | The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline. |
| Change From Baseline in C-peptide (Week 8). | Baseline and Week 8. | The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline. |
| Change From Baseline in C-peptide (Week 12). | Baseline and Week 12. | The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline. |
| Change From Baseline in C-peptide (Week 16). | Baseline and Week 16. | The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline. |
| Change From Baseline in C-peptide (Week 20). | Baseline and Week 20. | The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline. |
| Change From Baseline in C-peptide (Week 26). | Baseline and Week 26. | The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline. |
| Number of Participants With Glycosylated Hemoglobin ≤ 6.5%. | Baseline and Week 26. | The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study. |
| Number of Participants With Glycosylated Hemoglobin ≤ 7.0%. | Baseline and Week 26. | The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study. |
| Number of Participants With Glycosylated Hemoglobin ≤ 7.5%. | Baseline and Week 26. | The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study. |
| Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%. | Baseline and Week 26. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study. |
| Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%. | Baseline and Week 26. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study. |
| Change From Baseline in Insulin (Week 4). | Baseline and Week 4. | The change between the value of insulin collected at week 4 and insulin collected at baseline. |
| Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%. | Baseline and Week 26. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study. |
| Change From Baseline in Body Weight (Week 8). | Baseline and Week 8. | The change between Body Weight measured at week 8 and Body Weight measured at baseline. |
| Change From Baseline in Body Weight (Week 12). | Baseline and Week 12. | The change between Body Weight measured at week 12 and Body Weight measured at baseline. |
| Change From Baseline in Body Weight (Week 20). | Baseline and Week 20. | The change between Body Weight measured at week 20 and Body Weight measured at baseline. |
| Change From Baseline in Body Weight (Week 26). | Baseline and Week 26. | The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline. |
| Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%. | Baseline and Week 26. | The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study. |
Countries
Argentina, Australia, Brazil, Czechia, Germany, Guatemala, Hungary, India, Mexico, Netherlands, New Zealand, Peru, South Africa, United States
Participant flow
Recruitment details
Participants enrolled at 125 investigative sites in 13 countries from 24 February 2006 to 02 August 2007.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks. | 97 |
| Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks. | 197 |
| Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks. | 199 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 8 | 6 |
| Overall Study | Hyperglycemic rescue | 12 | 19 | 18 |
| Overall Study | Lost to Follow-up | 3 | 1 | 3 |
| Overall Study | Physician Decision | 5 | 5 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 10 | 9 |
Baseline characteristics
| Characteristic | Placebo | Alogliptin 12.5 mg QD | Alogliptin 25 mg QD | Total |
|---|---|---|---|---|
| Age, Customized <65 years | 83 participants | 165 participants | 160 participants | 408 participants |
| Age, Customized ≥75 years | 4 participants | 3 participants | 5 participants | 12 participants |
| Age, Customized Between 65 and 74 years | 10 participants | 29 participants | 34 participants | 73 participants |
| Sex: Female, Male Female | 44 Participants | 88 Participants | 74 Participants | 206 Participants |
| Sex: Female, Male Male | 53 Participants | 109 Participants | 125 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 97 | 76 / 198 | 79 / 199 |
| serious Total, serious adverse events | 4 / 97 | 5 / 198 | 13 / 199 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | -0.19 percentage of Glycosylated Hemoglobin | Standard Error 0.081 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | -0.66 percentage of Glycosylated Hemoglobin | Standard Error 0.056 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26. | -0.80 percentage of Glycosylated Hemoglobin | Standard Error 0.056 |
Comparison: Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.p-value: <0.00195% CI: [-0.67, -0.28]ANCOVA
Comparison: Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.p-value: <0.00195% CI: [-0.8, -0.41]ANCOVA
Secondary
Change From Baseline in Body Weight (Week 12).
The change between Body Weight measured at week 12 and Body Weight measured at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight (Week 12). | 0.60 kg | Standard Error 0.267 |
| Alogliptin 12.5 mg QD | Change From Baseline in Body Weight (Week 12). | 0.74 kg | Standard Error 0.187 |
| Alogliptin 25 mg QD | Change From Baseline in Body Weight (Week 12). | 0.64 kg | Standard Error 0.188 |
p-value: 0.67295% CI: [-0.5, 0.78]ANCOVA
p-value: 0.92295% CI: [-0.61, 0.67]ANCOVA
Secondary
Change From Baseline in Body Weight (Week 20).
The change between Body Weight measured at week 20 and Body Weight measured at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight (Week 20). | 0.94 kg | Standard Error 0.318 |
| Alogliptin 12.5 mg QD | Change From Baseline in Body Weight (Week 20). | 1.14 kg | Standard Error 0.222 |
| Alogliptin 25 mg QD | Change From Baseline in Body Weight (Week 20). | 0.93 kg | Standard Error 0.224 |
p-value: 0.60795% CI: [-0.56, 0.96]ANCOVA
p-value: 0.98595% CI: [-0.77, 0.76]ANCOVA
Secondary
Change From Baseline in Body Weight (Week 26).
The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight (Week 26). | 1.04 kg | Standard Error 0.329 |
| Alogliptin 12.5 mg QD | Change From Baseline in Body Weight (Week 26). | 1.46 kg | Standard Error 0.23 |
| Alogliptin 25 mg QD | Change From Baseline in Body Weight (Week 26). | 1.09 kg | Standard Error 0.232 |
p-value: 0.29495% CI: [-0.37, 1.22]ANCOVA
p-value: 0.995% CI: [-0.74, 0.84]ANCOVA
Secondary
Change From Baseline in Body Weight (Week 8).
The change between Body Weight measured at week 8 and Body Weight measured at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight (Week 8). | 0.36 kg | Standard Error 0.228 |
| Alogliptin 12.5 mg QD | Change From Baseline in Body Weight (Week 8). | 0.46 kg | Standard Error 0.16 |
| Alogliptin 25 mg QD | Change From Baseline in Body Weight (Week 8). | 0.39 kg | Standard Error 0.161 |
p-value: 0.71895% CI: [-0.45, 0.65]ANCOVA
p-value: 0.90695% CI: [-0.52, 0.58]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 12).
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 12). | -0.017 ng/mL | Standard Error 0.1226 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 12). | -0.085 ng/mL | Standard Error 0.0856 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 12). | -0.067 ng/mL | Standard Error 0.0856 |
p-value: 0.64995% CI: [-0.363, 0.226]ANCOVA
p-value: 0.73595% CI: [-0.344, 0.243]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 16).
The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 16). | -0.290 ng/mL | Standard Error 0.1135 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 16). | -0.071 ng/mL | Standard Error 0.0793 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 16). | -0.052 ng/mL | Standard Error 0.0793 |
p-value: 0.11495% CI: [-0.053, 0.492]ANCOVA
p-value: 0.08695% CI: [-0.033, 0.51]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 20).
The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 20). | -0.255 ng/mL | Standard Error 0.1029 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 20). | -0.228 ng/mL | Standard Error 0.0718 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 20). | -0.123 ng/mL | Standard Error 0.0719 |
p-value: 0.83595% CI: [-0.221, 0.273]ANCOVA
p-value: 0.29695% CI: [-0.115, 0.378]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 26).
The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 26). | -0.356 ng/mL | Standard Error 0.1071 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 26). | -0.233 ng/mL | Standard Error 0.0748 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 26). | -0.133 ng/mL | Standard Error 0.0748 |
p-value: 0.34995% CI: [-0.134, 0.38]ANCOVA
p-value: 0.08995% CI: [-0.034, 0.479]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 4).
The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 4). | -0.144 ng/mL | Standard Error 0.1108 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 4). | -0.156 ng/mL | Standard Error 0.0783 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 4). | -0.088 ng/mL | Standard Error 0.0794 |
p-value: 0.92895% CI: [-0.28, 0.255]ANCOVA
p-value: 0.68395% CI: [-0.212, 0.324]ANCOVA
Secondary
Change From Baseline in C-peptide (Week 8).
The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-peptide (Week 8). | -0.111 ng/mL | Standard Error 0.1127 |
| Alogliptin 12.5 mg QD | Change From Baseline in C-peptide (Week 8). | -0.117 ng/mL | Standard Error 0.0787 |
| Alogliptin 25 mg QD | Change From Baseline in C-peptide (Week 8). | 0.023 ng/mL | Standard Error 0.0788 |
p-value: 0.32795% CI: [-0.135, 0.405]ANCOVA
p-value: 0.96795% CI: [-0.277, 0.265]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 1).
The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 1.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 1). | -2.7 mg/dL | Standard Error 3.11 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 1). | -14.2 mg/dL | Standard Error 2.2 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 1). | -18.2 mg/dL | Standard Error 2.22 |
p-value: 0.00395% CI: [-18.9, -3.9]ANCOVA
p-value: <0.00195% CI: [-23, -8]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 12). | -9.9 mg/dL | Standard Error 3.33 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -20.4 mg/dL | Standard Error 2.34 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 12). | -26.2 mg/dL | Standard Error 2.33 |
p-value: 0.01195% CI: [-18.5, -2.4]ANCOVA
p-value: <0.00195% CI: [-24.3, -8.3]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 16).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 16). | -8.3 mg/dL | Standard Error 3.71 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -18.3 mg/dL | Standard Error 2.61 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 16). | -22.8 mg/dL | Standard Error 2.6 |
p-value: 0.02995% CI: [-18.9, -1]ANCOVA
p-value: 0.00295% CI: [-23.3, -5.5]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 2).
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 2.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 2). | -1.8 mg/dL | Standard Error 2.97 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 2). | -21.0 mg/dL | Standard Error 2.13 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 2). | -21.2 mg/dL | Standard Error 2.1 |
p-value: <0.00195% CI: [-26.4, -11.9]ANCOVA
p-value: <0.00195% CI: [-26.6, -12.3]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 20).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 20). | -6.4 mg/dL | Standard Error 3.58 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -21.9 mg/dL | Standard Error 2.52 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 20). | -21.6 mg/dL | Standard Error 2.51 |
p-value: <0.00195% CI: [-24.2, -6.9]ANCOVA
p-value: <0.00195% CI: [-23.8, -6.7]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 26).
The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 26). | -5.7 mg/dL | Standard Error 3.81 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 26). | -19.7 mg/dL | Standard Error 2.68 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 26). | -19.9 mg/dL | Standard Error 2.67 |
p-value: 0.00395% CI: [-23.1, -4.8]ANCOVA
p-value: 0.00395% CI: [-23.3, -5]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 4).
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller n at earlier timepoints due to unavailable prior values to carry forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 4). | -3.1 mg/dL | Standard Error 2.88 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 4). | -23.7 mg/dL | Standard Error 2.04 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 4). | -26.0 mg/dL | Standard Error 2.02 |
p-value: <0.00195% CI: [-27.5, -13.6]ANCOVA
p-value: <0.00195% CI: [-29.9, -16]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Plasma Glucose (Week 8). | -6.1 mg/dL | Standard Error 3.26 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 8). | -22.6 mg/dL | Standard Error 2.3 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Plasma Glucose (Week 8). | -27.1 mg/dL | Standard Error 2.29 |
p-value: <0.00195% CI: [-24.4, -8.7]ANCOVA
p-value: <0.00195% CI: [-28.9, -13.3]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 12).
The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 12). | 0.6 pmol/L | Standard Error 1.88 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 12). | -3.6 pmol/L | Standard Error 1.33 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 12). | -3.8 pmol/L | Standard Error 1.32 |
p-value: 0.06895% CI: [-8.8, 0.3]ANCOVA
p-value: 0.05695% CI: [-8.9, 0.1]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 16).
The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 16). | -3.1 pmol/L | Standard Error 1.89 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 16). | -3.5 pmol/L | Standard Error 1.33 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 16). | -3.1 pmol/L | Standard Error 1.32 |
p-value: 0.88495% CI: [-4.9, 4.2]ANCOVA
p-value: 0.99395% CI: [-4.5, 4.5]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 20).
The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 20). | -0.9 pmol/L | Standard Error 1.67 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 20). | -6.2 pmol/L | Standard Error 1.18 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 20). | -3.9 pmol/L | Standard Error 1.17 |
p-value: 0.00995% CI: [-9.4, -1.3]ANCOVA
p-value: 0.14395% CI: [-7, 1]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 26).
The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 26). | -1.0 pmol/L | Standard Error 1.9 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 26). | -5.1 pmol/L | Standard Error 1.34 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 26). | -1.7 pmol/L | Standard Error 1.33 |
p-value: 0.0895% CI: [-8.6, 0.5]ANCOVA
p-value: 0.78295% CI: [-5.2, 3.9]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 4).
The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 4). | -0.7 pmol/L | Standard Error 1.74 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 4). | -7.0 pmol/L | Standard Error 1.24 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 4). | -5.6 pmol/L | Standard Error 1.25 |
p-value: 0.00395% CI: [-10.6, -2.1]ANCOVA
p-value: 0.02395% CI: [-9.1, -0.7]ANCOVA
Secondary
Change From Baseline in Fasting Proinsulin (Week 8).
The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fasting Proinsulin (Week 8). | -2.3 pmol/L | Standard Error 1.7 |
| Alogliptin 12.5 mg QD | Change From Baseline in Fasting Proinsulin (Week 8). | -6.5 pmol/L | Standard Error 1.19 |
| Alogliptin 25 mg QD | Change From Baseline in Fasting Proinsulin (Week 8). | -3.7 pmol/L | Standard Error 1.19 |
p-value: 0.04395% CI: [-8.3, -0.1]ANCOVA
p-value: 0.48995% CI: [-5.5, 2.6]ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.23 percentage of Glycosylated Hemoglobin | Standard Error 0.069 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.70 percentage of Glycosylated Hemoglobin | Standard Error 0.048 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 12). | -0.82 percentage of Glycosylated Hemoglobin | Standard Error 0.048 |
p-value: <0.00195% CI: [-0.63, -0.3]ANCOVA
p-value: <0.00195% CI: [-0.75, -0.43]ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 16).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.26 percentage of Glycosylated Hemoglobin | Standard Error 0.076 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.70 percentage of Glycosylated Hemoglobin | Standard Error 0.053 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 16). | -0.84 percentage of Glycosylated Hemoglobin | Standard Error 0.053 |
p-value: <0.00195% CI: [-0.63, -0.26]ANCOVA
p-value: <0.00195% CI: [-0.76, -0.4]ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 20).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.27 percentage of Glycosylated Hemoglobin | Standard Error 0.078 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.68 percentage of Glycosylated Hemoglobin | Standard Error 0.055 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 20). | -0.82 percentage of Glycosylated Hemoglobin | Standard Error 0.055 |
p-value: <0.00195% CI: [-0.6, -0.22]ANCOVA
p-value: <0.00195% CI: [-0.74, -0.36]ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 4).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.14 percentage of Glycosylated Hemoglobin | Standard Error 0.042 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.40 percentage of Glycosylated Hemoglobin | Standard Error 0.029 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 4). | -0.45 percentage of Glycosylated Hemoglobin | Standard Error 0.03 |
p-value: <0.00195% CI: [-0.36, -0.16]ANCOVA
p-value: <0.00195% CI: [-0.41, -0.21]ANCOVA
Secondary
Change From Baseline in Glycosylated Hemoglobin (Week 8).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.18 percentage of Glycosylated Hemoglobin | Standard Error 0.061 |
| Alogliptin 12.5 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.60 percentage of Glycosylated Hemoglobin | Standard Error 0.042 |
| Alogliptin 25 mg QD | Change From Baseline in Glycosylated Hemoglobin (Week 8). | -0.73 percentage of Glycosylated Hemoglobin | Standard Error 0.042 |
p-value: <0.00195% CI: [-0.56, -0.27]ANCOVA
p-value: <0.00195% CI: [-0.69, -0.4]ANCOVA
Secondary
Change From Baseline in Insulin (Week 12).
The change between the value of insulin collected at week 12 and insulin collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 12). | 0.00 mcIU/mL | Standard Error 1.085 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 12). | 0.43 mcIU/mL | Standard Error 0.771 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 12). | -0.58 mcIU/mL | Standard Error 0.757 |
p-value: 0.74395% CI: [-2.18, 3.06]ANCOVA
p-value: 0.66295% CI: [-3.18, 2.02]ANCOVA
Secondary
Change From Baseline in Insulin (Week 16).
The change between the value of insulin collected at week 16 and insulin collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 16). | -0.85 mcIU/mL | Standard Error 0.701 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 16). | -0.10 mcIU/mL | Standard Error 0.501 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 16). | -0.16 mcIU/mL | Standard Error 0.492 |
p-value: 0.3995% CI: [-0.96, 2.45]ANCOVA
p-value: 0.42395% CI: [-1, 2.38]ANCOVA
Secondary
Change From Baseline in Insulin (Week 20).
The change between the value of insulin collected at week 20 and insulin collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 20). | -0.19 mcIU/mL | Standard Error 0.69 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 20). | -0.40 mcIU/mL | Standard Error 0.49 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 20). | -0.33 mcIU/mL | Standard Error 0.481 |
p-value: 0.80795% CI: [-1.87, 1.46]ANCOVA
p-value: 0.86795% CI: [-1.79, 1.51]ANCOVA
Secondary
Change From Baseline in Insulin (Week 26).
The change between the value of insulin collected at week 26 and insulin collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 26). | -0.81 mcIU/mL | Standard Error 0.711 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 26). | -0.19 mcIU/mL | Standard Error 0.505 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 26). | 0.00 mcIU/mL | Standard Error 0.495 |
p-value: 0.48395% CI: [-1.1, 2.33]ANCOVA
p-value: 0.35295% CI: [-0.89, 2.51]ANCOVA
Secondary
Change From Baseline in Insulin (Week 4).
The change between the value of insulin collected at week 4 and insulin collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 4). | -0.09 mcIU/mL | Standard Error 0.694 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 4). | -1.08 mcIU/mL | Standard Error 0.501 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 4). | -0.97 mcIU/mL | Standard Error 0.501 |
p-value: 0.24995% CI: [-2.68, 0.7]ANCOVA
p-value: 0.30395% CI: [-2.56, 0.8]ANCOVA
Secondary
Change From Baseline in Insulin (Week 8).
The change between the value of insulin collected at week 8 and insulin collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Insulin (Week 8). | -0.17 mcIU/mL | Standard Error 0.748 |
| Alogliptin 12.5 mg QD | Change From Baseline in Insulin (Week 8). | -0.82 mcIU/mL | Standard Error 0.531 |
| Alogliptin 25 mg QD | Change From Baseline in Insulin (Week 8). | 0.21 mcIU/mL | Standard Error 0.522 |
p-value: 0.47895% CI: [-2.46, 1.15]ANCOVA
p-value: 0.67495% CI: [-1.41, 2.17]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 12.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 12). | 0.017 ratio | Standard Error 0.019 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 12). | -0.029 ratio | Standard Error 0.0135 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 12). | -0.040 ratio | Standard Error 0.0132 |
p-value: 0.0595% CI: [-0.092, 0]ANCOVA
p-value: 0.01495% CI: [-0.102, -0.012]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 16.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 16). | -0.015 ratio | Standard Error 0.0153 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 16). | -0.042 ratio | Standard Error 0.0109 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 16). | -0.045 ratio | Standard Error 0.0107 |
p-value: 0.14495% CI: [-0.064, 0.009]ANCOVA
p-value: 0.10595% CI: [-0.067, 0.006]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 20.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 20). | 0.012 ratio | Standard Error 0.0168 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 20). | -0.047 ratio | Standard Error 0.0119 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 20). | -0.040 ratio | Standard Error 0.0117 |
p-value: 0.00495% CI: [-0.1, -0.019]ANCOVA
p-value: 0.01295% CI: [-0.092, -0.011]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 26). | 0.015 ratio | Standard Error 0.0185 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 26). | -0.035 ratio | Standard Error 0.0131 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 26). | -0.022 ratio | Standard Error 0.0129 |
p-value: 0.09395% CI: [-0.082, 0.006]ANCOVA
p-value: 0.02895% CI: [-0.095, -0.005]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 4.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller n at earlier timepoints due to unavailable prior values to carry forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 4). | 0.006 ratio | Standard Error 0.0144 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 4). | -0.051 ratio | Standard Error 0.0104 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 4). | -0.053 ratio | Standard Error 0.0104 |
p-value: 0.00195% CI: [-0.092, -0.022]ANCOVA
p-value: 0.00195% CI: [-0.093, -0.024]ANCOVA
Secondary
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
Time frame: Baseline and Week 8.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Proinsulin/Insulin Ratio (Week 8). | -0.006 ratio | Standard Error 0.0145 |
| Alogliptin 12.5 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 8). | -0.055 ratio | Standard Error 0.0103 |
| Alogliptin 25 mg QD | Change From Baseline in Proinsulin/Insulin Ratio (Week 8). | -0.057 ratio | Standard Error 0.0101 |
p-value: 0.00695% CI: [-0.084, -0.014]ANCOVA
p-value: 0.00495% CI: [-0.086, -0.016]ANCOVA
Secondary
Number of Participants Requiring Rescue.
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Time frame: 26 Weeks.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Requiring Rescue. | 12 participants |
| Alogliptin 12.5 mg QD | Number of Participants Requiring Rescue. | 19 participants |
| Alogliptin 25 mg QD | Number of Participants Requiring Rescue. | 18 participants |
p-value: 0.26695% CI: [0.277, 1.425]Regression, Logistic
p-value: 0.31595% CI: [0.292, 1.487]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin ≤ 6.5%. | 5 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 6.5%. | 34 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 6.5%. | 41 participants |
p-value: 0.00395% CI: [1.736, 13.358]Regression, Logistic
p-value: <0.00195% CI: [2.017, 15.176]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin ≤ 7.0%. | 33 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 7.0%. | 87 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 7.0%. | 98 participants |
p-value: 0.02995% CI: [1.067, 3.393]Regression, Logistic
p-value: 0.00595% CI: [1.291, 4.1]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin ≤ 7.5%. | 47 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 7.5%. | 127 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin ≤ 7.5%. | 141 participants |
p-value: <0.00195% CI: [1.547, 5.005]Regression, Logistic
p-value: <0.00195% CI: [2.147, 7.146]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%. | 26 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%. | 118 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%. | 128 participants |
p-value: <0.00195% CI: [2.392, 7.146]Regression, Logistic
p-value: <0.00195% CI: [3.027, 9.094]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%. | 12 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%. | 64 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%. | 73 participants |
p-value: <0.00195% CI: [1.789, 7.532]Regression, Logistic
p-value: <0.00195% CI: [2.303, 9.56]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%. | 5 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%. | 32 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%. | 37 participants |
p-value: 0.01595% CI: [1.3, 11.107]Regression, Logistic
p-value: 0.00295% CI: [1.806, 14.95]Regression, Logistic
Secondary
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.
Time frame: Baseline and Week 26.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%. | 3 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%. | 12 participants |
| Alogliptin 25 mg QD | Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%. | 14 participants |
p-value: 0.36495% CI: [0.459, 8.362]Regression, Logistic
p-value: 0.14695% CI: [0.696, 11.672]Regression, Logistic
Secondary
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.
Time frame: 26 Weeks.
Population: Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL). | 43 participants |
| Alogliptin 12.5 mg QD | Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL). | 49 participants |
| Alogliptin 25 mg QD | Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL). | 43 participants |
p-value: <0.00195% CI: [0.147, 0.499]Regression, Logistic
p-value: <0.00195% CI: [0.126, 0.438]Regression, Logistic