A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

Pfizer

Status and phase: Completed; Phase 2

Conditions: Treatment Of Obesity; Weight Management

Treatments: Drug: CE-326,597 5mg QD; Drug: Placebo; Drug: CE-326,597 50 mg QD; Drug: CE-326,597 100 mg QD; Drug: CE-326,597 25 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542009

A7211005

Details and patient eligibility

About

Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes

Enrollment: 252 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with type 2 diabetes, not on any or on oral (up to 2) anti-diabetic medications, otherwise medically stable.

Exclusion criteria

Women of childbearing potential, people with unstable medical conditions, people with gallstones

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 5 patient groups, including a placebo group

CE-326,597 100 mg QD

Experimental group

Treatment:

Drug: CE-326,597 100 mg QD

CE-326,597 50 mg QD

Experimental group

Treatment:

Drug: CE-326,597 50 mg QD

CE-326,597 25 mg QD

Experimental group

Treatment:

Drug: CE-326,597 25 mg QD

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CE-326,597 5mg QD

Experimental group

Treatment:

Drug: CE-326,597 5mg QD