Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01336738 |
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Recruitment Status :
Completed
First Posted : April 18, 2011
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief 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.
| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 266 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information available for:
Sitagliptin
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Matching placebo for PF-04991532 and Sitagliptin
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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 |
Primary Outcome Measures :
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ]HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Secondary Outcome Measures :
- Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 8 ]HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
- Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels [ Time Frame: Week 12 ]HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
- Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.
- Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline [ Time Frame: Week 12 ]Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.
- Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline [ Time Frame: Week 12 ]The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336738
Locations
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| Pfizer Investigational Site | |
| Jonesboro, Arkansas, United States, 72404 | |
| 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, 02914 | |
| Pfizer Investigational Site | |
| East Providence, Rhode Island, United States, 02915 | |
| 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, 77036 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77074 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77081 | |
| 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, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| 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 |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01336738 |
| Other Study ID Numbers: |
B2611002 |
| First Posted: | April 18, 2011 Key Record Dates |
| Results First Posted: | August 6, 2013 |
| Last Update Posted: | August 6, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Pfizer:
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Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Nicotinic Acids Sitagliptin Phosphate 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients |