Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

Study Overview
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Brief Summary
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Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

Official Title
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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.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI 1356
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control [glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BI 1356<br>5 mg orally (po) once daily | Drug: BI 1356<br>* 5mg orally (po) tablet qd<br>|
| Placebo Comparator: Placebo<br>one tablet once daily | Drug: Placebo<br>* Placebo matching BI 1356 5mg one tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose at Week 18 | Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 18 | 
| Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18 | An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks. | week 18 | 
| Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18 | An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks. | week 18 | 
| Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18 | An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks. | Baseline, week 18 | 
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6 | HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 6 | 
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12 | HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 12 | 
| Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18 | HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline, week 18 | 
| Change From Baseline in Fasting Plasma Glucose at Week 6 | Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 6 | 
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication. | Baseline, week 12 |