Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

Phase 3

Completed

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

• Registration Number: NCT00661362
• Lead Sponsor: AstraZeneca

Brief Summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Study Start: 2008-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-20
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-06
• Last Update Submitted: 2012-02-06
• Results First Posted: 2012-03-08
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• Diagnosed with Type 2 diabetes
• Treatment with metformin at a stable dose >1500 mg/day
• HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Metformin + Placebo
1	Metformin	Metformin + Saxagliptin
1	Saxagliptin	Metformin + Saxagliptin
2	Metformin	Metformin + Placebo

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)	Baseline , Week 24	Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline HbA1c.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup	Baseline , Week 24	Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L	Baseline , Week 24	Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.
Proportion of Patients Achieving a Therapeutic Glycemic Response	Baseline , Week 24	Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c \< 7.0% for saxagliptin + metformin versus placebo + metformin at week 24
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL	Baseline , Week 24	Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Uijeongbu-si, Korea, Republic of