Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
+41 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Pfizer
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
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
Treatment Details
Interventions
- 150 mg PF-04991532 (DPP-4 Inhibitor)
- 25 mg PF-04991532 (DPP-4 Inhibitor)
- 300 mg PF-04991532 (DPP-4 Inhibitor)
- 75 mg PF-04991532 (DPP-4 Inhibitor)
- Placebo (Drug)
- Sitagliptin 100 mg (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)
Participant Groups
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 75 mg PF-04991532Experimental Treatment1 Intervention
Group II: 300 mg PF-04991532Experimental Treatment1 Intervention
Group III: 25 mg PF-04991532Experimental Treatment1 Intervention
Group IV: 150 mg PF-04991532Experimental Treatment1 Intervention
Group V: Sitagliptin 100 mgActive Control1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention
Placebo for PF-04991532 and sitagliptin
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University