Clinical trial NCT01792635: A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Pharmacodynamics
Safety & Tolerability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glucose Infusion Rates (GIR) in Part A
timeFrame: 1 day
measure: Endogenous Gucose Production (EGP) in Part A
timeFrame: 1 day
measure: [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A
timeFrame: 1 day
measure: Rate of Appearance of Glucose (Ra) in Part A
timeFrame: 1 day
measure: Whole-body Glucose Uptake in Part A
timeFrame: 1 day
measure: Whole-body Glucose Uptake in Part B in Placebo Group
timeFrame: 6 weeks
measure: Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group
timeFrame: 6 weeks
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B
timeFrame: Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)
measure: Number of Participants With Laboratory Test Abnormalities in Part B
timeFrame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
measure: Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B
timeFrame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
measure: Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B
timeFrame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)
Secondary outcomes:
measure: GIR in Part B in Placebo Group
timeFrame: 6 weeks
measure: GIR in Part B in PF-05175157 200 mg BID Group
timeFrame: 6 weeks
measure: EGP in Part B in Placebo Group
timeFrame: 6 weeks
measure: EGP in Part B in PF-05175157 200 mg BID Group
timeFrame: 6 weeks
measure: Ra in Part B in Placebo Group
timeFrame: 6 weeks
measure: Ra in Part B in PF-05175157 200 mg BID Group
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc.
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: