| Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
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| 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
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| 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.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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| Diabetes, Type 2
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- 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
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- 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
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| Not Provided
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| Completed
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| 266
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| 240
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| March 2012
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| March 2012 (Final data collection date for primary outcome measure)
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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.
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| Sexes Eligible for Study: |
All |
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| 18 Years to 70 Years (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Canada, Hungary, Korea, Republic of, Mexico, Slovakia, Taiwan, United States
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| NCT01336738
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| B2611002
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| Yes
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| Not Provided
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| June 2013
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