Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
|
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: NCT01338870 |
|
Recruitment Status :
Completed
First Posted : April 20, 2011
Results First Posted : April 23, 2013
Last Update Posted : April 23, 2013
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: Placebo Drug: 25 mg PF-04991532 Drug: 75 mg PF-04991532 Drug: 150 mg PF-04991532 Drug: 300 mg PF-04991532 Drug: Sitagliptin 100 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 301 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 Twice Daily Pf-04991532 and Once Daily 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 |
|---|---|
|
Placebo Comparator: Placebo
Placebo for PF-04991532 and sitagliptin
|
Drug: Placebo
Tablets (n=4), 0 mg twice daily for 84 days |
| Experimental: 25 mg PF-04991532 |
Drug: 25 mg PF-04991532
Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
| Experimental: 75 mg PF-04991532 |
Drug: 75 mg PF-04991532
Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days |
| Experimental: 150 mg PF-04991532 |
Drug: 150 mg PF-04991532
Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
| Experimental: 300 mg PF-04991532 |
Drug: 300 mg PF-04991532
Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days |
| Active Comparator: Sitagliptin 100 mg |
Drug: Sitagliptin 100 mg
Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening 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% Gain in Body Weight From Baseline [ Time Frame: Week 12 ]Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.
- Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight 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% loss in body weight from baseline signifies an improvement of glycemia.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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): NCT01338870
Locations
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| Roseville, California, United States, 95661 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80209 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Coral Gables, Florida, United States, 33134 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| United States, Hawaii | |
| Pfizer Investigational Site | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Augusta, Kansas, United States, 67010 | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66215 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40504 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Maine | |
| Pfizer Investigational Site | |
| Auburn, Maine, United States, 04210 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Brooklyn Center, Minnesota, United States, 55430 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89101 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Trenton, New Jersey, United States, 08611 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28277 | |
| United States, North Dakota | |
| Pfizer Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45245 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Lansdale, Pennsylvania, United States, 19446 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | |
| Katy, Texas, United States, 77450 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Surrey, British Columbia, Canada, V4A 2H9 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Brampton, Ontario, Canada, L6T 0G1 | |
| Pfizer Investigational Site | |
| Mississauga, Ontario, Canada, L4Y 2N8 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Mirabel, Quebec, Canada, J7J 2K8 | |
| Canada | |
| Pfizer Investigational Site | |
| Quebec, Canada, G3K 2P8 | |
| Hungary | |
| Pfizer Investigational Site | |
| Balatonfured, Hungary, 8230 | |
| Pfizer Investigational Site | |
| Kistelek, Hungary, 6760 | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico, DF, Mexico, 06700 | |
| Pfizer Investigational Site | |
| Tlalnepantla, Estado de Mexico, Mexico, 54055 | |
| Pfizer Investigational Site | |
| Aguascalientes, Mexico, 20234 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 851 01 | |
| Pfizer Investigational Site | |
| Nove Mesto nad Vahom, Slovakia, 915 01 | |
| Pfizer Investigational Site | |
| Pezinok, Slovakia, 902 01 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 080 01 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Taichung, Taiwan, 40705 | |
| Pfizer Investigational Site | |
| Taoyuan County, Taiwan, 333 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01338870 |
| Other Study ID Numbers: |
B2611003 |
| First Posted: | April 20, 2011 Key Record Dates |
| Results First Posted: | April 23, 2013 |
| Last Update Posted: | April 23, 2013 |
| Last Verified: | March 2013 |
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 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 |