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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
First received: April 13, 2011
Last updated: June 5, 2013
Last verified: June 2013

April 13, 2011
June 5, 2013
June 2011
March 2012   (final data collection date for primary outcome measure)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.
Placebo-adjusted change from baseline in HbA1c (%) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01336738 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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 ]
  • As a measure of safety, SAEs and HAEs will be monitored. [ Time Frame: Up to Follow Up ] [ Designated as safety issue: Yes ]
    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 ] [ 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 ]
Not Provided
Not Provided
 
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes, Type 2
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
March 2012
March 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Taiwan,   Canada,   Hungary,   Korea, Republic of,   Mexico,   Slovakia
 
NCT01336738
B2611002
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2013

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