52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Phase 3

Completed

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

• Registration Number: NCT00575588
• Lead Sponsor: AstraZeneca

Brief Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-18
• Primary Completion: 2009-08
• Study Completion: 2010-08
• Results First Submitted: 2010-08-10
• Results First Submitted QC: 2010-08-10
• Results First Posted: 2010-09-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 891

Inclusion Criteria

• Diagnosed with type 2 diabetes,
• Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
• HbA1c >6.5% and ≤10.0%

Exclusion Criteria

• Type 1 diabetes,
• history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
• Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Metformin	-
Glipizide	Metformin	-
Glipizide	Sulphonylurea	-
Saxagliptin	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52	Baseline to 52 Weeks	Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks	From Baseline to Week 52	Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
Body Weight Change From Baseline to Week 52	Baseline, Week 52 (Last Observation Carried Forward)	Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c	Week 24 to Week 52	Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam