18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: saxagliptin; Drug: sitagliptin

• Registration Number: NCT00666458
• 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 sitagliptin in addition with metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-03
• Results First Submitted: 2010-03-05
• Results First Submitted QC: 2010-03-05
• Last Update Submitted: 2010-03-05
• Results First Posted: 2010-04-15
• Last Update Posted: 2010-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 822

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

Exclusion Criteria

• Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
• Insulin therapy within one year
• Previous treatment with DPP-4 inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	saxagliptin	saxagliptin add-on to metformin
2	sitagliptin	sitagliptin add-on to metformin

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18	Baseline, Week 18	Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol 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
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18	Week 18 (Last Observation Carried Forward)	Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set)
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)	Baseline, Week 18 (Last Observation Carried Forward)	Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)	Baseline, Week 18 (Last Observation Carried Forward)	Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Umea, Sweden