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

Study Overview
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Brief Summary
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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.

Official Title
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A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Saxagliptin
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Saxagliptin 5 mg | Drug: Saxagliptin<br>* 5 mg, oral tablet, once daily<br>* Other names: Onglyza;|
| Active Comparator: 2<br>Metformin 500 -1000 mg | Drug: Metformin<br>* 500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in HbA1c at Week 24 |  | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0% | Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent | 24 Weeks | 
| Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5% | Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent | 24 Weeks | 
| Change From Baseline to Week 24 in Fasting Plasma Glucose |  | Baseline and 24 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Saxagliptin, Randomised, Double-blind