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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01336738 |
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Date of registration:
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13/04/2011 |
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Primary sponsor: |
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Public title:
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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
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Scientific title:
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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 |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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267 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01336738 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Hungary
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Korea, Republic of
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Mexico
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Slovakia
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Taiwan
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes, Type 2
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Intervention(s)
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Drug: 150 mg PF-04991532
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Drug: 450 mg PF-04991532
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Drug: 750 mg PF-04991532
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Drug: Placebo
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Drug: Sitagliptin 100 mg
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Primary Outcome(s)
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Placebo-adjusted change from baseline in HbA1c (%)
[Time Frame: Day 84]
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Secondary Outcome(s)
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Change from baseline in body weight
[Time Frame: Up to Day 84]
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Change from baseline in fasting plasma glucose (mg/dL)
[Time Frame: Up to Day 84]
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Change from baseline in HbA1c
[Time Frame: Up to Day 84]
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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)
[Time Frame: Up to Follow Up]
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Proportion of subjects achieving HbA1c <7%, as well as the proportion achieving <6.5%
[Time Frame: Day 84]
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Proportion of subjects at Week 12 with body weight gain from baseline =1%
[Time Frame: Day 84]
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Proportion of subjects at Week 12 with body weight gain from baseline =2%
[Time Frame: Day 84]
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Proportion of subjects at Week 12 with body weight loss from baseline =1%
[Time Frame: Day 84]
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Proportion of subjects at Week 12 with body weight loss from baseline =2%.
[Time Frame: Day 84]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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