Phase 2
Completed N=301
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01338870 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 — 8.11; 7.90; 7.86; 7.93 percentage of hemoglobin — p=0.7606
Summary
B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 |
8.11; 7.90; 7.86; 7.93; 8.01; 8.05 | 0.7606 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 |
168.41; 167.71; 161.43; 163.38; 168.87; 170.42 | 0.3611 |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 |
0.03; -0.01; -0.07; -0.06; -0.02; -0.14 | 0.1797 |
| SECONDARY Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels |
11.9; 8.1; 15.4; 17.5; 17.4; 15.9 | — |
| SECONDARY Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 |
89.69; 87.24; 85.69; 85.44; 91.61; 91.00 | 0.5636 |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline |
23.81; 27.03; 38.46; 21.95; 15.22; 31.82 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline |
38.10; 35.14; 30.77; 48.78; 41.30; 40.91 | — |
Eligibility Criteria
Inclusion Criteria
Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2
Exclusion Criteria
Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.
Data sourced from ClinicalTrials.gov (NCT01338870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.