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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

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
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 13, 2011
First Posted Date  ICMJE April 18, 2011
Results First Submitted Date  ICMJE June 5, 2013
Results First Posted Date  ICMJE August 6, 2013
Last Update Posted Date August 6, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
Placebo-adjusted change from baseline in HbA1c (%) [ Time Frame: Day 84 ]
Change History Complete list of historical versions of study NCT01336738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: Up to Day 84 ]
  • Proportion of subjects achieving HbA1c <7%, as well as the proportion achieving <6.5% [ Time Frame: Day 84 ]
  • Change from baseline in body weight [ Time Frame: Up to Day 84 ]
  • As a measure of safety, SAEs and HAEs will be monitored. [ Time Frame: Up to Follow Up ]
    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)
  • Change from baseline in HbA1c [ Time Frame: Up to Day 84 ]
  • Proportion of subjects at Week 12 with body weight gain from baseline ≥1% [ Time Frame: Day 84 ]
  • Proportion of subjects at Week 12 with body weight loss from baseline ≥1% [ Time Frame: Day 84 ]
  • Proportion of subjects at Week 12 with body weight gain from baseline ≥2% [ Time Frame: Day 84 ]
  • Proportion of subjects at Week 12 with body weight loss from baseline ≥2%. [ Time Frame: Day 84 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Tablets (n=6), 0 mg, once daily for 84 days
  • Drug: 150 mg PF-04991532
    Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
  • Drug: 450 mg PF-04991532
    Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
  • Drug: 750 mg PF-04991532
    Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
  • Drug: Sitagliptin 100 mg
    Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo for PF-04991532 and Sitagliptin
    Intervention: Drug: Placebo
  • Experimental: 150 mg PF-04991532
    Intervention: Drug: 150 mg PF-04991532
  • Experimental: 450 mg PF-04991532
    Intervention: Drug: 450 mg PF-04991532
  • Experimental: 750 mg PF-04991532
    Intervention: Drug: 750 mg PF-04991532
  • Active Comparator: Sitagliptin 100 mg
    Intervention: Drug: Sitagliptin 100 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2013)
266
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
240
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   Canada,   Hungary,   Korea, Republic of,   Slovakia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336738
Other Study ID Numbers  ICMJE B2611002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP