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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Saxagliptin; Drug: Metformin XR

• Registration Number: NCT00960076
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-06-30
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Results First Posted: 2011-09-27
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saxagliptin	Saxagliptin
1	Metformin XR	Saxagliptin
2	Metformin XR	Metformin Extended Release

Primary Outcome Measures

Name	Time	Method
Change in HbA1c Level From Baseline to Week 18 (LOCF)	Baseline to week 18	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.

Secondary Outcome Measures

Name	Time	Method
Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)	Baseline to week 18	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.
Change in FPG From Baseline to Week 18 (LOCF)	Baseline to week 18	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.
Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)	Week 18 (LOCF)	Percent of subjects achieving therapeutic response (HbA1c \<7.0%) at Week 18 (LOCF) (Randomized analysis set)

Trial Locations

Locations (1)

Research Site; 🇵🇪 Lima, Peru