NCT01257334

Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,390 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c \> 10%)

Detailed description

Concomitant medications, including other treatments used to treat intercurrent medical conditions during the treatment period, will be recorded on the CRFs. This record will include the name of the medication, frequency, unit dose, dosage, the date when the drug is started and stopped, and the indication for the use of the drug. Prohibited The following treatments are prohibited in the trial 1. Other antidiabetic agents except for the background therapy (metformin or the combination of metformin plus sulfonylurea) 2. Treatment with anti-obesity drugs or systemic steroids 3. Other investigational medications

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	BI 10773	patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-09-01
• Completion: 2012-07-01
• First posted: 2010-12-09
• Last updated: 2010-12-09

Locations

1 site across 1 country: Taiwan