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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773 placebo; Drug: BI 10773 high dose; Drug: BI 10773 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011868

1245.33

2009-013668-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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494 participants in 3 patient groups, including a placebo group

BI 10773 low dose

Experimental group

Description:

Patients receive BI 10773 low dose daily

Treatment:

Drug: BI 10773 low dose

BI 10773 high dose

Experimental group

Description:

Patients receive BI 10773 high dose daily

Treatment:

Drug: BI 10773 high dose

Drug: BI 10773 placebo

Drug: BI 10773 placebo

placebo

Placebo Comparator group

Description:

Patients receive placebo to match BI 10773 daily

Treatment:

Drug: BI 10773 placebo

Drug: BI 10773 placebo