Clinical trial NCT02053103: A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin
Official title: A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 13
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
timeFrame: Baseline, Day 42
Secondary outcomes:
measure: Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
timeFrame: Weeks 0 and 4
measure: Change from baseline in fasting plasma glucose
timeFrame: Weeks 0, 2, 4 and 6
measure: Change from baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in fasting total cholesterol
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in homeostatic model assessment for β-cell function (HOMA B)
timeFrame: Weeks 0, 4 and 6
measure: Plasma concentrations for PF-05175157
timeFrame: Weeks 2, 4 and 6
measure: Percent change from baseline in body weight
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in low density lipoprotein cholesterol (LDL-C)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in high density lipoprotein cholesterol (HDL-C)
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in triglycerides
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in non-HDL cholesterol
timeFrame: Weeks 0, 4 and 6
measure: Change from baseline in very low density lipoprotein (VLDL)
timeFrame: Weeks 0, 4 and 6
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: