Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin once-daily; Drug: PF-04937319 once-daily; Drug: PF-04937319 split-dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01933672

B1621019

Details and patient eligibility

About

Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

Exclusion criteria

• Patients with cardiovascular event within 6-months of screening
• Patients with diabetic complications
• Female subjects who are pregnant or planning to become pregnant
• Subjects with unstable medical conditions (eg, hypertension)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 3 patient groups

PF-04937319 once-daily

Experimental group

Treatment:

Drug: PF-04937319 once-daily

PF-04937319 split-dose

Experimental group

Treatment:

Drug: PF-04937319 split-dose

Sitagliptin once-daily

Active Comparator group

Treatment:

Drug: Sitagliptin once-daily