Randomized, db, Placebo-Controlled 18 Week Study of BI 1356 in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000119

Enrollment

255

Registered

2009-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: BI 1356: 5 mg once daily (oral) Control Intervention1: Placebo: Matching 5 mg BI 1356

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) despite therapy with a sulfonylurea drug Age minimum: 18 Years Age maximum: 80 Years Gender: Both

Exclusion criteria

Exclusion criteria: Myocardial infarction,stroke or transient ischaemic attack in last 6 months - Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months - Impaired hepatic function - Severe renal impairment - Current treatment with systemic steroids - Change in thyroid hormone dosage - Hereditary galactose intolerance

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is change from baseline HbA1c after 18 weeks of treatment.Timepoint: After 18 weeks of treatment	—

Secondary

Measure	Time frame
HbA1c <7.0%Timepoint: After 18 weeks of treatment	—

Countries

India

Contacts

Public ContactJayesh Mahajan

Medpace Clinical Research India Pvt. Ltd.

j.mahajan@medpace.com02267863000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026