Phase 1
Completed N=43
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01933672 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14 — -31.24; -31.33; -19.24 milligram/deciliter (mg/dL)
Summary
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14 |
-31.24; -31.33; -19.24 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 |
-21.92; -20.70; -16.51 | — |
| SECONDARY Change From Baseline in Pre-meal C-Peptide on Day 14 |
-0.06; 0.06; 0.30; 0.20; 0.70; 0.06 | — |
| SECONDARY Change From Baseline in Pre-meal Insulin on Day 14 |
0.16; 0.46; 1.60; 1.69; 4.07; -0.01 | — |
| SECONDARY Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%) |
43; 31; 30; 30; 3; 16 | — |
| SECONDARY Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Body Weight (kg) |
0.50; 0.30; 0.05 | — |
| SECONDARY Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14 |
10710; 11810 | — |
| SECONDARY Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14 |
389.2; 423.3 | — |
| SECONDARY Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14 |
446.1; 492.0 | — |
| SECONDARY Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14 |
776.6; 980.5 | — |
| SECONDARY Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14 |
101.9; 131.0 | — |
| SECONDARY Plasma PF-04937319 Time for Cmax (Tmax) on Day 14 |
6.50; 5.00 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)
Exclusion Criteria
- Patients with cardiovascular event within 6-months of screening
- Patients with diabetic complications
- Female subjects who are pregnant or planning to become pregnant
- Subjects with unstable medical conditions (eg, hypertension)
Data sourced from ClinicalTrials.gov (NCT01933672). 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.