Japanese P III vs Voglibose and Placebo

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: voglibose; Drug: BI 1356 placebo; Drug: voglibose placebo; Drug: BI 1356

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654381

1218.23

Details and patient eligibility

About

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Enrollment: 561 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
3. Age: >= 20 and <= 80
4. Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
2. Impaired hepatic function
3. History of severe allergy/hypersensitivity
4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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561 participants in 4 patient groups, including a placebo group

voglibose 0.2 mg three times a day (TID)

Active Comparator group

Description:

patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356

Treatment:

Drug: voglibose

BI 1356 low dose

Experimental group

Description:

patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose

Treatment:

Drug: BI 1356

Drug: BI 1356

BI 1356 high dose

Experimental group

Description:

patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose

Treatment:

Drug: BI 1356

Drug: BI 1356

placebo

Placebo Comparator group

Description:

patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Treatment:

Drug: BI 1356 placebo

Drug: voglibose placebo