Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: 25 mg PF-04991532; Drug: 75 mg PF-04991532; Drug: 300 mg PF-04991532; Drug: 150 mg PF-04991532; Drug: Placebo; Drug: Sitagliptin 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338870

B2611003

Details and patient eligibility

About

B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Enrollment: 301 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion criteria

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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301 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for PF-04991532 and sitagliptin

Treatment:

Drug: Placebo

25 mg PF-04991532

Experimental group

Treatment:

Drug: 25 mg PF-04991532

75 mg PF-04991532

Experimental group

Treatment:

Drug: 75 mg PF-04991532

150 mg PF-04991532

Experimental group

Treatment:

Drug: 150 mg PF-04991532

300 mg PF-04991532

Experimental group

Treatment:

Drug: 300 mg PF-04991532

Sitagliptin 100 mg

Active Comparator group

Treatment:

Drug: Sitagliptin 100 mg