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Completed

NCT Number: NCT01338870

Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Tablets (n=4), 0 mg twice daily for 84 days

25 mg PF-04991532

Drug

Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days

75 mg PF-04991532

Drug

Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days

150 mg PF-04991532

Drug

Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days

300 mg PF-04991532

Drug

Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days

Sitagliptin 100 mg

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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