An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.

Official Title
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18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Saxagliptin
* Drug: Metformin XR
* Drug: Metformin XR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening A1c: 7.5-11% (at screening) BMI less than or equal to 45 kg/m2 Exclusion Criteria: Significant cardiovascular history Active liver disease, renal impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Saxagliptin | Drug: Saxagliptin<br>* 5mg oral tablet once daily<br>* Other names: Onglyza;Drug: Metformin XR<br>* 750mg, 2 tablets once daily<br>|
| Active Comparator: 2<br>Metformin Extended Release | Drug: Metformin XR<br>* 500mg oral tablet once daily<br>Drug: Metformin XR<br>* 750mg, 2 tablets once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c Level From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline to week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline to week 18 | 
| Change in FPG From Baseline to Week 18 (LOCF) | Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline to week 18 | 
| Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1) | Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set) | Week 18 (LOCF) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, Metformin, A1c