A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: PF-05175157

• Registration Number: NCT02053103
• Lead Sponsor: Pfizer

Brief Summary

A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Disposition First Submitted: 2016-03-29
• Disposition First Submitted QC: 2016-03-29
• Last Update Submitted: 2016-03-29
• Disposition First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
• Hemoglobin A1c of 7-10% at screening.
• Body Mass Index of at least 25 kg/m2.

Exclusion Criteria

• Compliant with study drug administration during the run-in period and throughout the trial.
• Patients with fasting triglycerides greater than 500 mg/dL at screening.
• History of certain diabetic complications or cardiac problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-05175157	PF-05175157	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo	Baseline, Day 42

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo	Weeks 0 and 4
Change from baseline in low density lipoprotein cholesterol (LDL-C)	Weeks 0, 4 and 6
Change from baseline in fasting total cholesterol	Weeks 0, 4 and 6
Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)	Weeks 0, 4 and 6
Change from baseline in Glycosylated Hemoglobin (HbA1c)	Weeks 0, 4 and 6
Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT	Weeks 0, 4 and 6
Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT	Weeks 0, 4 and 6
Percent change from baseline in body weight	Weeks 0, 4 and 6
Change from baseline in fasting plasma glucose	Weeks 0, 2, 4 and 6
Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)	Weeks 0, 4 and 6
Change from baseline in triglycerides	Weeks 0, 4 and 6
Change from baseline in high density lipoprotein cholesterol (HDL-C)	Weeks 0, 4 and 6
Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)	Weeks 0, 4 and 6
Plasma concentrations for PF-05175157	Weeks 2, 4 and 6
Change from baseline in homeostatic model assessment for β-cell function (HOMA B)	Weeks 0, 4 and 6
Change from baseline in non-HDL cholesterol	Weeks 0, 4 and 6
Change from baseline in very low density lipoprotein (VLDL)	Weeks 0, 4 and 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Orlando, Florida, United States