4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00558571

EudraCT No 2007-002685-36

1245.4

Details and patient eligibility

About

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

Enrollment: 78 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and postmenopausal or hysterectomised female patients with type 2 diabetes
• Age >18 and < 70 years
• BMI >18.5 and <40 kg/m2

Exclusion criteria

• Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
• Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
• HbA1c > 8.5 %

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo to BI 10773

BI 10773 low dose

Experimental group

Treatment:

Drug: BI 10773 low dose

BI 10773 medium dose

Experimental group

Treatment:

Drug: BI 10773 medium dose

BI 10773 high dose

Experimental group

Treatment:

Drug: BI 10773 high dose