4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: PF-06882961

Study type: Interventional

Funder types: Industry

Identifiers

NCT03538743

C3421002

Details and patient eligibility

About

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

Enrollment: 98 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes treated with a stable dose of metformin at least 500 mg
• HbA1c value between 7.0 and 10.5%

Exclusion criteria

• Type 1 diabetes or secondary forms of diabetes

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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98 participants in 9 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-06882961 30 mg

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 100 mg

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 300 mg

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 600 mg

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 dose TBD Cohort 5

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 dose TBD Cohort 6

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 dose TBD Cohort 7

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

PF-06882961 dose TBD Cohort 8

Experimental group

Treatment:

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961

Drug: PF-06882961