Diabetes
Conditions
Brief summary
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
Detailed description
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication
Interventions
DRUGSaxagliptin
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
DRUGMetformin
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
DRUGPlacebo
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
DRUGpioglitazone
Tablets, Oral, 15-45 mg, as needed (12 months LT)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Inadequate blood sugar control * No current treatment with other medications to lower blood sugar
Exclusion criteria
* Major heart, liver or kidney problems * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline in A1C at Week 24, adjusted for baseline value. |
| Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline in A1C at Week 24, adjusted for baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. |
| Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. |
| Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. |
| Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline, Week 24 | Mean change from baseline in FPG at Week 24, adjusted for baseline value. |
| Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. |
| Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. |
| Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 | Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. |
| Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 | Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline, Week 24 | Mean change from baseline in FPG at Week 24, adjusted for baseline value. |
Countries
Argentina, Brazil, Germany, Hungary, India, Italy, Mexico, Philippines, Poland, Puerto Rico, Russia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saxagliptin 5 mg + Metformin The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose. | 320 |
| Saxagliptin 10 mg + Metformin The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose. | 323 |
| Saxagliptin 10 mg The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin. | 335 |
| Metformin The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin. | 328 |
| Total | 1,306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative Reason by Sponsor | 1 | 2 | 2 | 1 |
| Overall Study | Adverse Event | 14 | 10 | 14 | 14 |
| Overall Study | Death | 1 | 2 | 2 | 3 |
| Overall Study | Lack of Efficacy | 18 | 18 | 35 | 29 |
| Overall Study | Lost to Follow-up | 22 | 23 | 29 | 22 |
| Overall Study | Physician Decision | 0 | 1 | 3 | 2 |
| Overall Study | Poor/Noncompliance | 11 | 8 | 4 | 5 |
| Overall Study | Pregnancy | 0 | 2 | 1 | 1 |
| Overall Study | Subject no longer meets study criteria | 4 | 2 | 8 | 7 |
| Overall Study | Withdrawal of Consent by Subject | 20 | 24 | 28 | 25 |
Baseline characteristics
| Characteristic | Saxagliptin 5 mg + Metformin | Saxagliptin 10 mg + Metformin | Saxagliptin 10 mg | Metformin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.95 years STANDARD_DEVIATION 10.43 | 52.08 years STANDARD_DEVIATION 11.59 | 52.09 years STANDARD_DEVIATION 10.17 | 51.83 years STANDARD_DEVIATION 10.74 | 51.99 years STANDARD_DEVIATION 10.73 |
| Sex: Female, Male Female | 155 Participants | 177 Participants | 166 Participants | 165 Participants | 663 Participants |
| Sex: Female, Male Male | 165 Participants | 146 Participants | 169 Participants | 163 Participants | 643 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 106 / 328 | 106 / 335 | 122 / 323 | 116 / 320 |
| serious Total, serious adverse events | 15 / 328 | 16 / 335 | 22 / 323 | 16 / 320 |
Outcome results
Primary
Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 6.93 percent | Standard Error 0.066 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -2.53 percent | Standard Error 0.07 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 9.41 percent | Standard Error 0.072 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -2.49 percent | Standard Error 0.069 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 9.53 percent | Standard Error 0.069 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 7.02 percent | Standard Error 0.067 |
| Saxagliptin 10 mg | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 7.48 percent | Standard Error 0.084 |
| Saxagliptin 10 mg | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 9.43 percent | Standard Error 0.073 |
| Saxagliptin 10 mg | Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -1.99 percent | Standard Error 0.069 |
Primary
Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), subjects must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 6.93 percent | Standard Error 0.066 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 9.41 percent | Standard Error 0.072 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -2.53 percent | Standard Error 0.07 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 7.02 percent | Standard Error 0.067 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 9.53 percent | Standard Error 0.069 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -2.49 percent | Standard Error 0.069 |
| Saxagliptin 10 mg | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 9.61 percent | Standard Error 0.075 |
| Saxagliptin 10 mg | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -1.69 percent | Standard Error 0.069 |
| Saxagliptin 10 mg | Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 7.86 percent | Standard Error 0.085 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 140.2 mg/dL | Standard Error 2.39 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 198.9 mg/dL | Standard Error 3.17 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -59.8 mg/dL | Standard Error 2.34 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 140.1 mg/dL | Standard Error 2.34 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 204.3 mg/dL | Standard Error 3.35 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -62.2 mg/dL | Standard Error 2.34 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 199.1 mg/dL | Standard Error 3.28 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -47.3 mg/dL | Standard Error 2.33 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 152.7 mg/dL | Standard Error 2.8 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 198.9 mg/dL | Standard Error 3.17 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -59.8 mg/dL | Standard Error 2.34 |
| Saxagliptin 5 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 140.2 mg/dL | Standard Error 2.39 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 204.3 mg/dL | Standard Error 3.35 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -62.2 mg/dL | Standard Error 2.34 |
| Saxagliptin 10 mg + Metformin | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 140.1 mg/dL | Standard Error 2.34 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -30.9 mg/dL | Standard Error 2.3 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 169.9 mg/dL | Standard Error 3.2 |
| Saxagliptin 10 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 200.9 mg/dL | Standard Error 3.03 |
Secondary
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 35324 mg*min/dL | Standard Error 890 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 55531 mg*min/dL | Standard Error 1116.5 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -21080 mg*min/dL | Standard Error 836.5 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 35790 mg*min/dL | Standard Error 888.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 57219 mg*min/dL | Standard Error 1169.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -21336 mg*min/dL | Standard Error 869.6 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Baseline Mean | 57937 mg*min/dL | Standard Error 1281.7 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Adjusted Mean Change from Baseline | -15005 mg*min/dL | Standard Error 857 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | Week 24 Mean | 42428 mg*min/dL | Standard Error 1082.1 |
Secondary
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Time frame: Baseline, Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 55531 mg*min/dL | Standard Error 1116.5 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -21080 mg*min/dL | Standard Error 836.5 |
| Saxagliptin 5 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 35324 mg*min/dL | Standard Error 890 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 57219 mg*min/dL | Standard Error 1169.6 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 35790 mg*min/dL | Standard Error 888.9 |
| Saxagliptin 10 mg + Metformin | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -21336 mg*min/dL | Standard Error 869.6 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Baseline Mean | 57584 mg*min/dL | Standard Error 1143.4 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Adjusted Mean Change from Baseline | -16054 mg*min/dL | Standard Error 826.7 |
| Saxagliptin 10 mg | Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | Week 24 Mean | 41229 mg*min/dL | Standard Error 1050.9 |
Secondary
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 45.3 Percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 40.6 Percentage of participants |
| Saxagliptin 10 mg | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 29.0 Percentage of participants |
Secondary
Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 45.3 Percentage of Participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 40.6 Percentage of Participants |
| Saxagliptin 10 mg | Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 20.3 Percentage of Participants |
Secondary
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 60.3 Percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 59.7 Percentage of participants |
| Saxagliptin 10 mg | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 41.1 Percentage of participants |
Secondary
Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Percentage of participants achieving A1C \< 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 60.3 Percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 59.7 Percentage of participants |
| Saxagliptin 10 mg | Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 32.2 Percentage of participants |
Secondary
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 7.5 Percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 5.9 Percentage of participants |
| Saxagliptin 10 mg | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy | 10.1 Percentage of participants |
Secondary
Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone.
Time frame: Week 24
Population: Randomized participants who took at least 1 dose of double-blind treatment were included in the Week 24 LOCF analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Saxagliptin 5 mg + Metformin | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 7.5 Percentage of participants |
| Saxagliptin 10 mg + Metformin | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 5.9 Percentage of participants |
| Saxagliptin 10 mg | Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy | 21.2 Percentage of participants |