Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 1356; Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg; Drug: Glimepiride; Drug: Placebo identical to BI 1356 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622284

1218.20

2007-004585-40 (EudraCT Number)

Details and patient eligibility

About

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Enrollment: 1,560 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,560 participants in 2 patient groups

BI 1356 5mg, once daily

Experimental group

Description:

patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride

Treatment:

Drug: BI 1356

Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg

Glimepiride

Active Comparator group

Description:

patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)

Treatment:

Drug: Glimepiride

Drug: Placebo identical to BI 1356 5mg