Phase 2
Completed N=376
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01475461 ↗Enrolled (actual)
376
Serious AEs
0.4%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 — 8.01; 8.00; 7.80; 8.15 percentage of hemoglobin — p=0.5206
Summary
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 |
8.01; 8.00; 7.80; 8.15; 8.31; 7.89 | 0.5206 |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8 |
-0.20; -0.24; -0.32; -0.35; -0.50; -0.52 | 0.3434 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14 |
168.3; 159.8; 155.1; 166.1; 164.8; 160.7 | 0.7240 |
| SECONDARY Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 |
12.5; 9.4; 19.1; 15.4; 17.6; 32.1 | — |
| SECONDARY Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data |
0; 1; 0; 0; 1; 2 | — |
| SECONDARY Number of Participants With Increase/Decrease From Baseline Vital Signs Data |
1; 2; 2; 1; 3; 2 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
37; 19; 19; 19; 16; 24 | — |
| SECONDARY Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode |
0; 0; 0; 1; 0; 2 | — |
| SECONDARY Number of Hypoglycemic Events (HAE) Episodes Per Participant |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14 |
86.446; 87.865; 88.371; 88.066; 91.239; 87.025 | 0.0913 |
| SECONDARY Number of Participants With Abnormal Laboratory Values |
46; 49; 45; 46; 53; 43 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01475461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.