Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Official Title
-----------------
A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

Conditions
-----------------
Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo
* Drug: BI 10773
* Drug: BI 10773


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of T2DM prior to informed consent Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose HbA1c >=7.5% and <=10% at screening Exclusion criteria: Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in Any contraindications to metformin according to the local label Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>BI 10773 low dose once daily | Drug: Placebo<br>* Placebo matching BI 10773 high dose<br>Drug: BI 10773<br>* BI 10773 low dose once daily<br>|
| Experimental: BI 10773 high dose<br>BI 10733 high dose once daily | Drug: Placebo<br>* Placebo matching BI 10773 low dose<br>Drug: BI 10773<br>* BI 10773 high dose once daily<br>|
| Placebo Comparator: Placebo<br>Placebo tablets matching BI 10773 | Drug: Placebo<br>* Placebo matching BI 10773 low dose<br>Drug: Placebo<br>* Placebo matching BI 10773 high dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c After 18 Weeks of Treatment | The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment. | Baseline and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Insulin Dose After 52 Weeks of Treatment | The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment | Baseline and 52 weeks | 
| Change From Baseline in Body Weight After 52 Weeks of Treatment | The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment | Baseline and 52 weeks | 
| Change From Baseline in HbA1c After 52 Weeks of Treatment | The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment | Baseline and 52 weeks |