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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 13, 2011
• First Posted Date: April 18, 2011
• Results First Submitted Date: June 5, 2013
• Results First Posted Date: August 6, 2013
• Last Update Posted Date: August 6, 2013
• Study Start Date: June 2011
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetes, Type 2

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2013): 266
• Original Estimated Enrollment (submitted: April 14, 2011): 240
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico, Canada, Hungary, Korea, Republic of, Slovakia, Taiwan, United States

Administrative Information

• NCT Number: NCT01336738
• Other Study ID Numbers: B2611002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2013