Type 2 Diabetes Clinical Trial
Official title:
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
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%)
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
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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