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

Phase 2TerminatedNCT02053103

Pfizer13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

PF-05175157DRUG

Tablet, 200 mg, twice daily, 6 weeks

PlaceboDRUG

Tablet, 0 mg, twice daily, 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Orlando, Florida, United States

Outcomes

Primary Outcomes

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo

Time frame: Baseline, Day 42

Secondary Outcomes

Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo

Time frame: Weeks 0 and 4

Change from baseline in fasting plasma glucose

Time frame: Weeks 0, 2, 4 and 6

Change from baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Weeks 0, 4 and 6

Change from baseline in fasting total cholesterol

Time frame: Weeks 0, 4 and 6

Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)

Time frame: Weeks 0, 4 and 6

Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)

Time frame: Weeks 0, 4 and 6

Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT

Time frame: Weeks 0, 4 and 6

Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT

Time frame: Weeks 0, 4 and 6

Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)

Time frame: Weeks 0, 4 and 6

Change from baseline in homeostatic model assessment for β-cell function (HOMA B)

Data from ClinicalTrials.gov

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