Phase 2
Completed N=361
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Source: ClinicalTrials.gov NCT01517373 ↗Enrolled (actual)
361
Serious AEs
1.4%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 — 7.90; 7.97; 7.91; 7.88 percentage of hemoglobin — p=0.4468
Summary
This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 |
7.90; 7.97; 7.91; 7.88; 8.12; -0.13 | 0.4468 |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 |
-0.08; -0.07; -0.22; -0.32; -0.54; -0.14 | 0.6112 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 |
161.3; 168.7; 174.7; 160.4; 163.7; 3.1 | 0.3446 |
| SECONDARY Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 |
7.0; 13; 18.5; 27.3; 18.2; 26.3 | — |
| SECONDARY Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Increase/Decrease From Baseline Vital Signs Data |
2; 1; 3; 3; 5; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
26; 28; 31; 29; 36; 0 | — |
| SECONDARY Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode |
4.9; 3.3; 4.9; 6.6; 34.4 | — |
| SECONDARY Number of Hypoglycemic Events (HAE) Episodes Per Participant |
0; 0; 0; 0; 0 | — |
| SECONDARY Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant |
— | — |
| SECONDARY Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14 |
89.859; 89.518; 89.860; 87.530; 90.388; -0.402 | 0.0898 |
| SECONDARY Number of Participants With Abnormal Laboratory Values |
56; 52; 56; 54; 51 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent
Exclusion Criteria
- Subjects with recent cardiovascular events, those with evidence of diabetic complications
Data sourced from ClinicalTrials.gov (NCT01517373). 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.