Phase 1
Completed N=48
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT01298518 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 — 1052.7; 954.7; 1005.4; -118.3 mg*hr/dL
Summary
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 |
1052.7; 954.7; 1005.4; -118.3; -143.0; -117.7 | — |
| SECONDARY Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 |
204.9; 188.0; 187.2; -25.4; -23.4; -18.3 | — |
| SECONDARY Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 |
122.9; 220.2; 156.7; 12.4; 0.6; 41.0 | — |
| SECONDARY Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 |
17.8; 21.6; 20.3; -0.2; -4.0; -0.2 | — |
| SECONDARY Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28 |
860.6; 1014.4; 961.2; -185.0; -100.5; -110.3 | — |
| SECONDARY Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 |
54.4; 63.2; 70.2; 25.3; 4.7; -17.5 | — |
| SECONDARY Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 |
1372.8; 1181.0; 1619.2; -141.6; -277.1; 46.8 | — |
| SECONDARY Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28 |
409.0; 540.7; 395.0; 196.6; 96.7; 24.4 | — |
| SECONDARY Change From Baseline in Fasting Glucose at Day 28 |
197.2; 180.9; 194.4; -46.9; -27.1; -25.2 | — |
| SECONDARY Change From Baseline in Fasting Insulin at Day 28 |
10.2; 19.8; 9.2; -0.8; -8.0; 0.2 | — |
| SECONDARY Change From Baseline in Fasting Net Triglycerides at Day 28 |
189.1; 234.8; 187.4; -31.2; -18.4; -19.2 | — |
| SECONDARY Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28 |
853.4; 772.3; 730.2; -34.9; -41.4; -90.4 | — |
| SECONDARY Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28 |
851.2; 763.9; 759.4; -132.8; -104.8; -41.4 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-04620110 |
91.0; 112.0 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 |
16.2; 5.2 | — |
| SECONDARY Time to Cmax (Tmax) of PF-04620110 |
3.0; 3.0 | — |
| SECONDARY Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 |
1055; 1027 | — |
Eligibility Criteria
Inclusion Criteria
- Male and/or female subjects between the ages of 18 and 60 years;
- Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;
- Subjects must have a historical diagnosis of T2DM in accordance with the ADA guidelines;
- Subjects who have been on well-tolerated and stable doses of metformin
Exclusion Criteria
- Recent evidence (6 months prior to screening) or history of unstable major organ disease;
- Diagnosis of Type 1 diabetes mellitus;
- Current medical history of myocardial infarction, unstable angina, or history of stroke (including TIA) within 6 months prior to Screening;
- Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic agents;
Data sourced from ClinicalTrials.gov (NCT01298518). 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.