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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin; Insulin

Criteria

Inclusion criteria:

1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

2. 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.

3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and < or = 10% at Visit 1 (screening)

4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)

5. Age > or =18 years at Visit 1 (screening)

6. BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

1. Patients with poorly controlled hyperglycemia

2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy

3. MI, stroke, or TIA within 3 months prior to obtaining informed consent

4. 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