Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGPF-05175157
Tablet, 200 mg, twice daily, 6 weeks
DRUGPlacebo
Tablet, 0 mg, twice daily, 6 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo | Baseline, Day 42 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in homeostatic model assessment for β-cell function (HOMA B) | Weeks 0, 4 and 6 |
| Plasma concentrations for PF-05175157 | Weeks 2, 4 and 6 |
| Change from baseline in Glycosylated Hemoglobin (HbA1c) | 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 insulin AUC(0-5) during mixed meal tolerance test (MMTT) | 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 |
| Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR) | Weeks 0, 4 and 6 |
| Change from baseline in fasting plasma glucose | Weeks 0, 2, 4 and 6 |
| Percent change from baseline in body weight | Weeks 0, 4 and 6 |
| Change from baseline in low density lipoprotein cholesterol (LDL-C) | Weeks 0, 4 and 6 |
| Change from baseline in high density lipoprotein cholesterol (HDL-C) | Weeks 0, 4 and 6 |
| Change from baseline in triglycerides | 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 |
| Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo | Weeks 0 and 4 |
Countries
United States
Outcome results
None listed