Japanese P III vs Voglibose and Placebo

Study Overview
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Brief Summary
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The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Official Title
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A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI 1356
* Drug: BI 1356
* Drug: voglibose placebo
* Drug: BI 1356 placebo
* Drug: voglibose


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase) Age: >= 20 and <= 80 Body Mass Index (BMI) <= 40 kg/m2 Exclusion criteria: Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1 Impaired hepatic function History of severe allergy/hypersensitivity Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1 Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Ages Eligible for Study
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Minimum Age: 20 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: voglibose 0.2 mg three times a day (TID)<br>patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356 | Drug: voglibose<br>* 0.6 mg/daily<br>|
| Experimental: BI 1356 low dose<br>patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose | Drug: BI 1356<br>* 5 mg/daily<br>|
| Experimental: BI 1356 high dose<br>patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose | Drug: BI 1356<br>* 10 mg/daily<br>|
| Placebo Comparator: placebo<br>patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose | Drug: voglibose placebo<br>* three times daily<br>Drug: BI 1356 placebo<br>* once 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 at Week 12 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication | 12 weeks | 
| Change From Baseline in HbA1c at Week 26 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication | 26 weeks | 
| Examination of Long-term Safety of Linagliptin (52-week Treatment) | The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Efficacy Response of HbA1c at Week 12 | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12 | 12 weeks | 
| Relative Efficacy Response of HbA1c at Week 26 | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26 | 26 weeks | 
| Relative Efficacy Response of HbA1c at Week 52 | HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52 | 52 weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication | 12 weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication | 26 weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication | 52 weeks |