Phase 2
Completed N=266
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Diabetes, Type 2
Source: ClinicalTrials.gov NCT01336738 ↗
Enrolled (actual)
266
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 — 8.34; 8.19; 7.96; 7.97 percentage of hemoglobin — p=0.6803
Summary
B2611002 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 5 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 |
8.34; 8.19; 7.96; 7.97; 8.55; -0.17 | 0.6803 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 |
172.68; 169.16; 159.11; 158.38; 183.61; 0.87 | 0.4757 |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 |
-0.04; -0.03; -0.13; -0.07; -0.02; -0.04 | 0.2327 |
| SECONDARY Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels |
4.5; 9.1; 23.3; 14.6; 11.6; 13.6 | — |
| SECONDARY Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 |
92.57; 88.91; 86.08; 87.48; 87.43; -0.10 | 0.2067 |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline |
17.78; 18.18; 15.56; 29.17; 23.26; 6.67 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline |
55.56; 47.73; 46.67; 29.17; 41.86; 26.67 | — |
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 (NCT01336738). 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.