A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 As Monotherapy In Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01792635
• Other study ID #: B1731003
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2012
• Last updated: July 2, 2014
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess the safety, tolerability and pharmacodynamics of 6 weeks of oral doses of PF-05175157 provided as monotherapy in subjects with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects who have been diagnosed with type 2 diabetes mellitus by a medical professional according to the American Diabetes Association guidelines.

• Hemoglobin A1c of =7 and =10.0% in subjects who are metformin-naive or have not taken metformin for 2 months or Hemoglobin A1c of =6.5 and =9.5% in subjects who are metformin-naïve and are taking SU or DPP-IVi which is washed off or taking metformin and are willing to discontinue metformin in a 8-week washout period.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine (other than T2DM and hypothyroidism), gastrointestinal, cardiovascular, pulmonary, hepatic, psychiatric or neurologic disease.

• A waist circumference which makes fitting imto the bore of the MR scanner impossible.

Subjects with history of dry eye, known ocular or systemic disease that affect the sclera or cornea.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• PF-05175157
PF-05175157 will be administered at 200 mg twice a day for 43 days.
• Placebo
Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose infusion rates		1 day	No
Primary	Endogenous glucose production	Endogenous glucose production measured by means of euglycemic hyperinsulinemic clamp	1 day	No
Primary	Whole-body glucose uptake		6 weeks	No
Secondary	Rate of appearance of glucose in fasting state and during insulin infusions		6 weeks	No
Secondary	Glucose infusion rates at steady-state during Step 1 and Step 2 insulin infusions		6 weeks	No

External Links

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