A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: PF-04937319 high dose; Drug: PF-04937319 low dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292433

B1621018

Details and patient eligibility

About

Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy

Enrollment: 12 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Exclusion criteria

• Patients with cardiovascular event
• 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: Double Blind

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12 participants in 2 patient groups, including a placebo group

PF-04937319

Experimental group

Description:

PF-04937319 Split dose

Treatment:

Drug: PF-04937319 low dose

Drug: PF-04937319 high dose

Placebo

Placebo Comparator group

Description:

Placebo split dose

Treatment:

Drug: Placebo