Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: PF-04937319 IR MST; Drug: PF-04937319 MR 1; Drug: PF-04937319 MR 2; Drug: PF-04937319 MR 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02206607

B1621015

Details and patient eligibility

About

Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)

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: None (Open label)

---

39 participants in 4 patient groups

PF-04937319 IR MST

Experimental group

Description:

Reference formulation

Treatment:

Drug: PF-04937319 IR MST

PF-04937319 MR 1

Experimental group

Description:

Test MR #1

Treatment:

Drug: PF-04937319 MR 1

PF-04937319 MR 2

Experimental group

Description:

Test MR #2

Treatment:

Drug: PF-04937319 MR 2

PF-04937319 MR 3

Experimental group

Description:

Test MR #3

Treatment:

Drug: PF-04937319 MR 3