Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01475461
• Date of registration: 15/09/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
• Scientific title: A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
• Date of first enrolment: November 2011
• Target sample size: 345
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01475461
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Hungary, India, Philippines, Romania, Slovakia, South Africa, Taiwan, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

- patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory
test results at screening



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: PF-04937319 - 20mg

Drug: PF-04937319 - 3mg

Drug: Sitagliptin - 100mg

Drug: Placebo

Drug: PF-04937319 - 100mg

Drug: PF-04937319 - 50mg

Primary Outcome(s)

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 [Time Frame: Baseline (Day 1), Week 12]

Secondary Outcome(s)

Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14 [Time Frame: Baseline (Day 1), Week 2, 4, 8 , 12 , 14]

Number of Participants With Abnormal Laboratory Values [Time Frame: Baseline (Day 1) up to Week 14]

Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode [Time Frame: Baseline (Day 1) up to Week 14]

Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 [Time Frame: Week 12]

Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14 [Time Frame: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14]

Number of Hypoglycemic Events (HAE) Episodes Per Participant [Time Frame: Baseline (Day 1) up to Week 14]

Number of Participants With Increase/Decrease From Baseline Vital Signs Data [Time Frame: Baseline (Day 1) up to Week 14]

Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8 [Time Frame: Baseline(Day 1), Week 2, 4, 8]

Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data [Time Frame: Baseline (Day 1) up to Week 14]

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Baseline (Day 1) up to 14 days after last dose (up to 101 days)]

Secondary ID(s)

2011-004002-25

B1621007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01475461