Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-04937319 50 mg; Drug: PF-04937319 100 mg; Drug: Glimepiride; Drug: Placebo; Drug: PF-04937319 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01517373

2011-005206-30 (EudraCT Number)

B1621002

Details and patient eligibility

About

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin

Enrollment: 304 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion criteria

• Subjects with recent cardiovascular events, those with evidence of diabetic complications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to match PF-04937319 and glimepiride

Treatment:

Drug: Placebo

PF-04937319 10 mg

Experimental group

Treatment:

Drug: PF-04937319 10 mg

PF-04937319 50 mg

Experimental group

Treatment:

Drug: PF-04937319 50 mg

PF-04937319 100 mg

Experimental group

Treatment:

Drug: PF-04937319 100 mg

Glimepiride

Active Comparator group

Treatment:

Drug: Glimepiride