Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01006590
• Lead Sponsor: AstraZeneca

Brief Summary

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-31
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Study Completion: 2010-12
• Results First Submitted: 2011-11-30
• Results First Submitted QC: 2011-11-30
• Status Verified: 2012-01
• Results First Posted: 2012-01-05
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Provision of signed informed consent
• Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
• HbA1c ≥7.0% and ≤10.0%

Exclusion Criteria

• Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
• Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
• Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Saxagliptin	Saxagliptin 5 mg
2	Metformin	Metformin 500 -1000 mg

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in HbA1c at Week 24	Baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 24 in Fasting Plasma Glucose	Baseline and 24 weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%	24 Weeks	Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%	24 Weeks	Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
Change From Baseline to Week 24 in Fasting Insulin	Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta	Baseline and 24 weeks

Trial Locations

Locations (1)

Research Site; 🇬🇧 Peterborough, United Kingdom