Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

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 BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Official Title
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A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI 10773 placebo
* Drug: BI 10773 low dose
* Drug: BI 10773 high dose
* Drug: BI 10773 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening) Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study) Age > or =18 years at Visit 1 (screening) BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening) Exclusion criteria: Patients with poorly controlled hyperglycemia Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy MI, stroke, or TIA within 3 months prior to obtaining informed consent Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias 6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: BI 10773 low dose<br>Patients receive BI 10773 low dose daily | Drug: BI 10773 low dose<br>* BI 10773 low dose<br>|
| Experimental: BI 10773 high dose<br>Patients receive BI 10773 high dose daily | Drug: BI 10773 placebo<br>* BI 10773 placebo<br>Drug: BI 10773 high dose<br>* BI 10773 high dose<br>|
| Placebo Comparator: placebo<br>Patients receive placebo to match BI 10773 daily | Drug: BI 10773 placebo<br>* BI 10773 placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment | Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment | Baseline and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment | Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment | Baseline and 18, 54 and 78 weeks | 
| Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment | Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment | Baseline, 18, 54 and 78 weeks | 
| Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment | Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment | Baseline, 18, 54 and 78 weeks | 
| Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment | Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment | Baseline, 54 and 78 weeks | 
| Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment | Change from baseline in body weight after 18, 54 and 78 weeks of treatment | Baseline, 18, 54, 78 weeks | 
| Change From Baseline in Body Weight at Follow-up | Change from baseline in body weight at follow up (82 weeks) | Baseline and 82 weeks | 
| Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment | Change from baseline in HbA1c after 54 and 78 weeks of treatment | Baseline, 54 and 78 weeks | 
| The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment | The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment | Baseline, 18, 54 and 78 weeks |