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CompletedNCT01338870Updated Apr 23, 2013Results posted

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

A Phase 2 interventional study of Placebo and 25 mg PF-04991532 in Diabetes Mellitus, Type 2, sponsored by Pfizer. Completed at 42 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-23.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
301
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Phase 2
  • safety and efficacy study with PF-04991532
  • Type 2 diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 301 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
301 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo for PF-04991532 and sitagliptin

    Drug: Placebo

  • Experimental
    25 mg PF-04991532

    Drug: 25 mg PF-04991532

  • Experimental
    75 mg PF-04991532

    Drug: 75 mg PF-04991532

  • Experimental
    150 mg PF-04991532

    Drug: 150 mg PF-04991532

  • Experimental
    300 mg PF-04991532

    Drug: 300 mg PF-04991532

  • Active comparator
    Sitagliptin 100 mg

    Drug: Sitagliptin 100 mg

Interventions

  • DrugPlacebo

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

  • Drug25 mg PF-04991532

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

  • Drug75 mg PF-04991532

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

  • Drug150 mg PF-04991532

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

  • Drug300 mg PF-04991532

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

  • DrugSitagliptin 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.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.

    Time frame: Baseline, Week 12

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

    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.

    Time frame: Baseline, Week 1, 2, 4, 8

  3. Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels

    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.

    Time frame: Week 12

  4. Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 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.

    Time frame: Baseline, Week 1, 2, 4, 8, 12

  5. Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline

    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.

    Time frame: Week 12

  6. Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline

    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.

    Time frame: Week 12

07

Results

Posted Apr 23, 2013

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
Started504950505250
Completed413739414644
Not completed91211966
Withdrew: Lost to follow-up001010
Withdrew: Withdrawal by subject234002
Withdrew: Other333202
Withdrew: Protocol violation022211
Withdrew: Adverse event441541

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.

Time frame:
Baseline, Week 12
Reported as:
Mean · percentage of hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
percentage of hemoglobinPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
Baseline (n= 50, 49, 50, 50, 52, 50)8.11 ± 1.2557.90 ± 0.9397.86 ± 0.9987.93 ± 1.0188.01 ± 1.0648.05 ± 0.958
Change at Week 12 (n= 42, 37, 39, 40, 46, 44)-0.30 ± 0.681-0.15 ± 0.593-0.51 ± 0.847-0.36 ± 0.828-0.79 ± 0.743-0.65 ± 0.754
Statistical analysis
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.7606 · Least squares (ls) mean difference: 0.10 · 80% CI -0.08 to 0.29
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0266 · Ls mean difference: -0.28 · 80% CI -0.46 to -0.09
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.0440 · Ls mean difference: -0.24 · 80% CI -0.42 to -0.06
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0001 · Ls mean difference: -0.53 · 80% CI -0.71 to -0.36
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0013 · Ls mean difference: -0.43 · 80% CI -0.60 to -0.25
SecondaryChange From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Time frame:
Baseline, Week 1, 2, 4, 8, 12
Reported as:
Mean · milligram/deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
milligram/deciliter (mg/dL)PlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
Baseline (n= 50, 49, 50, 50 ,52, 50)168.41 ± 51.859167.71 ± 52.401161.43 ± 43.009163.38 ± 44.976168.87 ± 47.630170.42 ± 41.366
Change at Week 1 (n= 48, 47, 47, 46, 46, 45)3.69 ± 24.632-0.70 ± 26.644-3.29 ± 20.131-3.75 ± 19.486-15.35 ± 35.673-18.59 ± 30.637
Change at Week 2 (n= 44, 44, 45, 45, 47, 48)-1.31 ± 21.7461.05 ± 22.186-3.84 ± 24.007-1.68 ± 26.966-16.68 ± 43.620-20.13 ± 32.632
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)2.00 ± 36.0676.08 ± 24.687-6.56 ± 32.8803.61 ± 36.385-19.84 ± 31.334-18.90 ± 28.434
Change at Week 8 (n= 43, 40, 41, 42, 46, 45)5.63 ± 26.1839.42 ± 28.172-4.98 ± 30.6964.43 ± 28.491-14.24 ± 42.128-17.84 ± 28.715
Change at Week 12 (n= 42, 37, 38, 40, 46, 44)3.41 ± 34.4308.06 ± 23.298-6.55 ± 31.9196.20 ± 38.122-16.80 ± 35.765-16.07 ± 31.298
Statistical analysis
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.3611 · Ls mean difference: -5.21 · 95% CI -16.40 to 5.98
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0969 · Ls mean difference: -9.45 · 95% CI -20.61 to 1.71
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.1566 · Ls mean difference: -8.10 · 95% CI -19.30 to 3.11
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0052 · Ls mean difference: -15.92 · 95% CI -27.06 to -4.77
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0002 · Ls mean difference: -21.09 · 95% CI -32.30 to -9.88
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.9893 · Ls mean difference: 0.08 · 95% CI -11.41 to 11.56
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.4767 · Ls mean difference: -4.14 · 95% CI -15.55 to 7.27
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.6222 · Ls mean difference: -2.87 · 95% CI -14.28 to 8.55
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0159 · Ls mean difference: -13.88 · 95% CI -25.16 to -2.61
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0012 · Ls mean difference: -18.69 · 95% CI -29.95 to -7.44
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.5125 · Ls mean difference: 3.86 · 95% CI -7.71 to 15.43
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.1455 · Ls mean difference: -8.47 · 95% CI -19.89 to 2.94
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.8712 · Ls mean difference: 0.94 · 95% CI -10.43 to 12.31
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0006 · Ls mean difference: -19.57 · 95% CI -30.77 to -8.36
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0008 · Ls mean difference: -19.08 · 95% CI -30.26 to -7.90
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.2488 · Ls mean difference: 6.99 · 95% CI -4.90 to 18.87
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.2084 · Ls mean difference: -7.56 · 95% CI -19.34 to 4.23
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.9053 · Ls mean difference: 0.71 · 95% CI -11.01 to 12.43
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0091 · Ls mean difference: -15.30 · 95% CI -26.79 to -3.81
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0016 · Ls mean difference: -18.62 · 95% CI -30.15 to -7.09
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.2963 · Ls mean difference: 6.50 · 95% CI -5.71 to 18.70
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.1159 · Ls mean difference: -9.71 · 95% CI -21.82 to 2.40
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.4413 · Ls mean difference: 4.70 · 95% CI -7.28 to 16.68
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0099 · Ls mean difference: -15.30 · 95% CI -26.91 to -3.68
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0126 · Ls mean difference: -14.95 · 95% CI -26.69 to -3.21
SecondaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 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.

Time frame:
Baseline, Week 1, 2, 4, 8
Reported as:
Mean · percentage of hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
percentage of hemoglobinPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
Change at Week 1 (n= 48, 47, 47, 46, 46, 47)0.03 ± 0.496-0.01 ± 0.190-0.07 ± 0.182-0.06 ± 0.227-0.02 ± 0.210-0.14 ± 0.223
Change at Week 2 (n= 45, 44, 45, 45, 47, 48)-0.02 ± 0.481-0.10 ± 0.236-0.08 ± 0.230-0.06 ± 0.342-0.17 ± 0.275-0.21 ± 0.357
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)-0.14 ± 0.558-0.15 ± 0.326-0.26 ± 0.436-0.32 ± 0.525-0.37 ± 0.395-0.40 ± 0.463
Change at Week 8 (n= 43, 40, 41, 42, 45, 45)-0.26 ± 0.615-0.14 ± 0.492-0.40 ± 0.697-0.42 ± 0.708-0.58 ± 0.607-0.54 ± 0.696
Statistical analysis
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.1797 · Ls mean difference: -0.05 · 80% CI -0.13 to 0.02
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0234 · Ls mean difference: -0.12 · 95% CI -0.19 to -0.04
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.0400 · Ls mean difference: -0.10 · 80% CI -0.18 to -0.03
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.1568 · Ls mean difference: -0.06 · 80% CI -0.13 to 0.02
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0010 · Ls mean difference: -0.18 · 80% CI -0.25 to -0.11
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.0695 · Ls mean difference: -0.10 · 80% CI -0.19 to -0.01
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0636 · Ls mean difference: -0.11 · 80% CI -0.20 to -0.02
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.0512 · Ls mean difference: -0.11 · 80% CI -0.20 to -0.02
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0051 · Ls mean difference: -0.18 · 80% CI -0.26 to -0.09
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0009 · Ls mean difference: -0.22 · 80% CI -0.30 to -0.13
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.2392 · Ls mean difference: -0.07 · 80% CI -0.19 to 0.05
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0308 · Ls mean difference: -0.17 · 80% CI -0.29 to -0.05
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.0019 · Ls mean difference: -0.27 · 80% CI -0.38 to -0.15
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0034 · Ls mean difference: -0.24 · 80% CI -0.36 to -0.13
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0002 · Ls mean difference: -0.32 · 80% CI -0.44 to -0.21
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.7854 · Ls mean difference: 0.10 · 80% CI -0.06 to 0.26
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.0778 · Ls mean difference: -0.18 · 80% CI -0.33 to -0.02
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.0065 · Ls mean difference: -0.31 · 80% CI -0.46 to -0.15
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.0011 · Ls mean difference: -0.37 · 80% CI -0.52 to -0.21
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.0013 · Ls mean difference: -0.37 · 80% CI -0.52 to -0.21
SecondaryPercentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels

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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
percentage of participantsPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
< 6.5%11.98.115.417.517.415.9
< 7%23.829.738.535.043.536.4
SecondaryChange From Baseline in Body Weight at Week 1, 2, 4, 8 and 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.

Time frame:
Baseline, Week 1, 2, 4, 8, 12
Reported as:
Mean · kilogram (kg)
Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
kilogram (kg)PlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
Baseline (n= 50, 49, 50, 50, 52, 50)89.69 ± 17.57187.24 ± 19.80585.69 ± 19.80585.44 ± 18.30591.61 ± 21.82291.00 ± 21.013
Change at Week 1 (n= 48, 47, 47, 46, 47, 47)0.01 ± 0.792-0.20 ± 1.1700.14 ± 1.600-0.20 ± 0.861-0.20 ± 1.168-0.33 ± 2.089
Change at Week 2 (n= 45, 44, 45, 45, 47, 48)0.31 ± 2.041-0.49 ± 1.4620.07 ± 1.510-0.25 ± 1.086-0.03 ± 1.414-0.32 ± 2.488
Change at Week 4 (n= 46, 42, 44, 45, 48, 49)-0.10 ± 1.255-0.55 ± 1.5760.20 ± 1.594-0.27 ± 1.381-0.58 ± 1.401-0.30 ± 2.276
Change at Week 8 (n= 43, 40, 41, 42, 46, 45)-0.21 ± 1.848-0.57 ± 1.488-0.04 ± 2.318-0.64 ± 1.538-0.67 ± 1.649-0.61 ± 2.648
Change at Week 12 (n= 42, 37, 39, 41, 46, 44)-0.30 ± 1.869-0.71 ± 1.980-0.15 ± 2.757-0.83 ± 2.099-0.75 ± 2.087-0.83 ± 3.026
Statistical analysis
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.5636 · Ls mean difference: -0.16 · 95% CI -0.69 to 0.38
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.4889 · Ls mean difference: 0.19 · 95% CI -0.35 to 0.72
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.5849 · Ls mean difference: -0.15 · 95% CI -0.68 to 0.39
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.5104 · Ls mean difference: -0.18 · 95% CI -0.70 to 0.35
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.2640 · Ls mean difference: -0.30 · 95% CI -0.83 to 0.23
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.0464 · Ls mean difference: -0.71 · 95% CI -1.42 to -0.01
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.7107 · Ls mean difference: -0.13 · 95% CI -0.83 to 0.56
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.1564 · Ls mean difference: -0.50 · 95% CI -1.19 to 0.19
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.3834 · Ls mean difference: -0.30 · 95% CI -0.98 to 0.38
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.1279 · Ls mean difference: -0.53 · 95% CI -1.21 to 0.15
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.2520 · Ls mean difference: -0.39 · 95% CI -1.06 to 0.28
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.2772 · Ls mean difference: 0.37 · 95% CI -0.30 to 1.03
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.7038 · Ls mean difference: -0.13 · 95% CI -0.79 to 0.53
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.2031 · Ls mean difference: -0.42 · 95% CI -1.07 to 0.23
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.6948 · Ls mean difference: -0.13 · 95% CI -0.78 to 0.52
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.5691 · Ls mean difference: -0.24 · 95% CI -1.07 to 0.59
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.3447 · Ls mean difference: 0.39 · 95% CI -0.42 to 1.21
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.5769 · Ls mean difference: -0.23 · 95% CI -1.04 to 0.58
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.3599 · Ls mean difference: -0.37 · 95% CI -1.16 to 0.42
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.4600 · Ls mean difference: -0.30 · 95% CI -1.10 to 0.50
  • Placebo vs PF-04991532 25 mg · Mixed Models Analysis · p = 0.4253 · Ls mean difference: -0.40 · 95% CI -1.39 to 0.59
  • Placebo vs PF-04991532 75 mg · Mixed Models Analysis · p = 0.4349 · Ls mean difference: 0.39 · 95% CI -0.59 to 1.37
  • Placebo vs PF-04991532 150 mg · Mixed Models Analysis · p = 0.6697 · Ls mean difference: -0.21 · 95% CI -1.18 to 0.76
  • Placebo vs PF-04991532 300 mg · Mixed Models Analysis · p = 0.5501 · Ls mean difference: -0.28 · 95% CI -1.22 to 0.65
  • Placebo vs Sitagliptin 100 mg · Mixed Models Analysis · p = 0.4081 · Ls mean difference: -0.40 · 95% CI -1.35 to 0.55
SecondaryPercentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline

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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline
percentage of participantsPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
>= 1%23.8127.0338.4621.9515.2231.82
>= 2%2.382.7015.387.326.5215.91
SecondaryPercentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline

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.

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline
percentage of participantsPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
>= 1%38.1035.1430.7748.7841.3040.91
>= 2%23.8127.0317.9526.8330.4329.55

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/50 (0%)14/50 (28%)
PF-04991532 25 mg—0/49 (0%)16/49 (32.7%)
PF-04991532 75 mg—0/50 (0%)14/50 (28%)
PF-04991532 150 mg—0/50 (0%)11/50 (22%)
PF-04991532 300 mg—0/52 (0%)15/52 (28.8%)
Sitagliptin 100 mg—0/50 (0%)11/50 (22%)
Most frequent other events
Most frequent other events
EventPlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mg
HyperglycaemiaMetabolism and nutrition disorders3/505/490/503/501/521/50
Urinary tract infectionInfections and infestations5/501/492/503/500/522/50
HeadacheNervous system disorders0/504/494/501/503/521/50
NasopharyngitisInfections and infestations0/501/490/501/501/524/50
PharyngitisInfections and infestations1/502/492/501/504/520/50
DizzinessNervous system disorders0/503/490/500/501/520/50
DiarrhoeaGastrointestinal disorders2/500/493/501/502/520/50
Upper respiratory tract infectionInfections and infestations3/501/493/502/502/521/50
HypoglycaemiaMetabolism and nutrition disorders0/501/490/501/501/523/50
HypertensionVascular disorders1/501/492/500/503/520/50

Baseline characteristics

Age Continuous
Age Continuous(years)PlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mgTotal
Mean55.7 ± 8.859.2 ± 6.856.1 ± 8.657.2 ± 8.756.0 ± 7.755.6 ± 9.056.6 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-04991532 25 mgPF-04991532 75 mgPF-04991532 150 mgPF-04991532 300 mgSitagliptin 100 mgTotal
Female163021203015132
Male341929302235169
08

Study locations

42 sites
  • Pfizer Investigational Site
    Little Rock, Arkansas 72205, United States
  • Pfizer Investigational Site
    Roseville, California 95661, United States
  • Pfizer Investigational Site
    Denver, Colorado 80209, United States
  • Pfizer Investigational Site
    Coral Gables, Florida 33134, United States
  • Pfizer Investigational Site
    Ocala, Florida 34471, United States
  • Pfizer Investigational Site
    Honolulu, Hawaii 96814, United States
  • Pfizer Investigational Site
    Indianapolis, Indiana 46260, United States
  • Pfizer Investigational Site
    Augusta, Kansas 67010, United States
  • Pfizer Investigational Site
    Overland Park, Kansas 66215, United States
  • Pfizer Investigational Site
    Wichita, Kansas 67207, United States
  • Pfizer Investigational Site
    Lexington, Kentucky 40504, United States
  • Pfizer Investigational Site
    Lake Charles, Louisiana 70601, United States
  • Pfizer Investigational Site
    Auburn, Maine 04210, United States
  • Pfizer Investigational Site
    Brooklyn Center, Minnesota 55430, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada 89101, United States
  • Pfizer Investigational Site
    Trenton, New Jersey 08611, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina 28277, United States
  • Pfizer Investigational Site
    Fargo, North Dakota 58103, United States
  • Pfizer Investigational Site
    Cincinnati, Ohio 45245, United States
  • Pfizer Investigational Site
    Lansdale, Pennsylvania 19446, United States
  • Pfizer Investigational Site
    Dallas, Texas 75246, United States
  • Pfizer Investigational Site
    Katy, Texas 77450, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78229, United States
  • Pfizer Investigational Site
    Norfolk, Virginia 23502, United States
  • Pfizer Investigational Site
    Richmond, Virginia 23294, United States
  • Pfizer Investigational Site
    Surrey, British Columbia V4A 2H9, Canada
  • Pfizer Investigational Site
    Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada
  • Pfizer Investigational Site
    Brampton, Ontario L6T 0G1, Canada
  • Pfizer Investigational Site
    Mississauga, Ontario L4Y 2N8, Canada
  • Pfizer Investigational Site
    Mirabel, Quebec J7J 2K8, Canada
  • Pfizer Investigational Site
    Quebec, G3K 2P8, Canada
  • Pfizer Investigational Site
    Balatonfured, 8230, Hungary
  • Pfizer Investigational Site
    Kistelek, 6760, Hungary
  • Pfizer Investigational Site
    Mexico, DF 06700, Mexico
  • Pfizer Investigational Site
    Tlalnepantla, Estado de Mexico 54055, Mexico
  • Pfizer Investigational Site
    Aguascalientes, 20234, Mexico
  • Pfizer Investigational Site
    Bratislava, 851 01, Slovakia
  • Pfizer Investigational Site
    Nove Mesto nad Vahom, 915 01, Slovakia
  • Pfizer Investigational Site
    Pezinok, 902 01, Slovakia
  • Pfizer Investigational Site
    Presov, 080 01, Slovakia
  • Pfizer Investigational Site
    Taichung, 40705, Taiwan
  • Pfizer Investigational Site
    Taoyuan County, 333, Taiwan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01338870
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 20, 2011
Start date
Jun 2011
Primary completion
Mar 2012
Completion
Mar 2012
Results posted
Apr 23, 2013
Last update
Apr 23, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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