| Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus |
| A 12-Week, Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-04991532 And Sitagliptin In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Diabetes, Type 2 |
- Drug: Placebo
Tablets (n=6), 0 mg, once daily for 84 days
- Drug: 150 mg PF-04991532
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
- Drug: 450 mg PF-04991532
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
- Drug: 750 mg PF-04991532
Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
- Drug: Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
|
- Placebo Comparator: Placebo
Matching placebo for PF-04991532 and Sitagliptin
Intervention: Drug: Placebo
- Experimental: 150 mg PF-04991532
Intervention: Drug: 150 mg PF-04991532
- Experimental: 450 mg PF-04991532
Intervention: Drug: 450 mg PF-04991532
- Experimental: 750 mg PF-04991532
Intervention: Drug: 750 mg PF-04991532
- Active Comparator: Sitagliptin 100 mg
Intervention: Drug: Sitagliptin 100 mg
|
| Not Provided |
| |
| Completed |
| 266 |
| March 2012 |
| March 2012 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada, Hungary, Korea, Republic of, Mexico, Slovakia, Taiwan, United States |
| |
| |
| NCT01336738 |
| B2611002 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| June 2013 |
