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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:
Information provided by (Responsible Party):
Pfizer

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

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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

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 :
  1. 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 :
  1. Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]
  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

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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): NCT01338870


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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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:
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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
Nutrients
Growth Substances