Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
First received: April 13, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes, Type 2 |
Drug: Placebo Drug: 150 mg PF-04991532 Drug: 450 mg PF-04991532 Drug: 750 mg PF-04991532 Drug: Sitagliptin 100 mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Placebo-adjusted change from baseline in HbA1c (%) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
- Proportion of subjects achieving HbA1c <7%, as well as the proportion achieving <6.5% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
- Change from baseline in body weight [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
- Clinical laboratory tests, 12 lead ECGs, vital signs, adverse events (AEs), as well as serious AEs (SAEs) and including episodes of hypoglycemic adverse events (HAEs) [ Time Frame: Up to Follow Up ] [ Designated as safety issue: Yes ]
- Change from baseline in HbA1c [ Time Frame: Up to Day 84 ] [ Designated as safety issue: No ]
- Proportion of subjects at Week 12 with body weight gain from baseline ≥1% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
- Proportion of subjects at Week 12 with body weight loss from baseline ≥1% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
- Proportion of subjects at Week 12 with body weight gain from baseline ≥2% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
- Proportion of subjects at Week 12 with body weight loss from baseline ≥2%. [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
| Enrollment: | 267 |
| Study Start Date: | June 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matching placebo for PF-04991532 and Sitagliptin
|
Drug: Placebo
Tablets (n=6), 0 mg, once daily for 84 days
|
| Experimental: 150 mg PF-04991532 |
Drug: 150 mg PF-04991532
Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
|
| Experimental: 450 mg PF-04991532 |
Drug: 450 mg PF-04991532
Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
|
| Experimental: 750 mg PF-04991532 |
Drug: 750 mg PF-04991532
Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
|
| Active Comparator: Sitagliptin 100 mg |
Drug: Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336738
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| United States, Arkansas | |
| Pfizer Investigational Site | |
| Jonesboro, Arkansas, United States, 72404 | |
| Pfizer Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90057 | |
| Pfizer Investigational Site | |
| Palm Springs, California, United States, 92262 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Melbourne, Florida, United States, 32901 | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Conyers, Georgia, United States, 30094 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60607 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11230 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Cary, North Carolina, United States, 27518 | |
| Pfizer Investigational Site | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43213 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| East Providence, Rhode Island, United States, 02915 | |
| Pfizer Investigational Site | |
| East Providence, Rhode Island, United States, 02914 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| Pfizer Investigational Site | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77081 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77036 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77074 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Charlottesville, Virginia, United States, 22911 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Kenosha, Wisconsin, United States, 53142 | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Strathroy, Ontario, Canada, N7G 1Y7 | |
| Pfizer Investigational Site | |
| Thornhill, Ontario, Canada, L4J 8L7 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Laval, Quebec, Canada, H7T 2P5 | |
| Pfizer Investigational Site | |
| St-Romuald, Quebec, Canada, G6W 5M6 | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1036 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Mexico | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44130 | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44650 | |
| Pfizer Investigational Site | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 831 01 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Tainan, Taiwan, 710 | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01336738 History of Changes |
| Other Study ID Numbers: | B2611002 |
| Study First Received: | April 13, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013