A study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes

Phase 3

Completed

• Conditions: Health Condition 1: null- Type 2 DiabetesHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2010/091/001110
• Lead Sponsor: AstraZeneca Singapore Pte Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-06-14
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

Written Informed Consent

- Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c more or equal 7 percentage and less or equal 10 percentage) despite being on combination of metformin and sulfonylurea for at least 8 weeks.

- BMI less or equal 40 kg/m2

Exclusion Criteria

- Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with more 10% weight loss in 3 months prior to entry, or other signs and symptoms

- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma

- Current or prior use (within 3 months of entry) of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin, gliclazide, gliclazide MR or glimepiride)

- Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor

- Estimated CrCl less 60ml/min

- CHF (NYHA class III or IV) and/or LVEF less 40%

- Active liver disease and/or significant abnormal liver function

- Creatine kinase more or equal 10 x ULN

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare change in HbA1c from Baseline to Week 24/Endpoint between the treatment groupsTimepoint: HbA1c will be measured every 4 weeks during treatment period.

Secondary Outcome Measures

Name	Time	Method
Compare change in FPG from Baseline to Week 24/Endpoint between the treatment groupsTimepoint: From Baseline to Week 24. <br>FPG will be measured every 4 weeks during treatment period.<br>Patients will self-monitor FPG at least every second day<br>;Compare change in PPG from Baseline to Week24/Endpoint between the treatment groupsTimepoint: From Baseline to Week 24. <br>PPG will be measured prior to administration of first dose of saxagliptin and at completion of study treatment<br>;Safety and tolerability will be evaluated by assessment of AEs (including hypoglycaemic events); lab values; changes in renal functionTimepoint: AEs will be recorded at every study visit (every 4 weeks).<br>Patients will record information about hypoglycaemic events throughout the entire study period<br>