A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298518
First received: January 28, 2011
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Patients |
Drug: PF-04620110 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 1B, Randomized, Double-Blind, Placebo-Controlled Trial To Assess The Efficacy And Safety Of 4-Week Administration Of Multiple Oral Doses Of PF-04620110 In Type 2 Diabetes Mellitus Subjects With Insufficient Glycemic Control On Metformin |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
Secondary Outcome Measures:
- Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28 [ Time Frame: Baseline (Day -1); 24 hours post-dose on Day 28 ] [ Designated as safety issue: No ]APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.
- 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 [ Time Frame: Baseline (Day -1); 2 to 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.
- Change From Baseline in Fasting Glucose at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Insulin at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Net Triglycerides at Day 28 [ Time Frame: 0 hour (pre-dose) on Day -1, Day 28 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Baseline (Day -1); 6 to 10 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
- 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 [ Time Frame: Baseline (Day -1); 12 to 16 hours post-dose on Day 28 ] [ Designated as safety issue: No ]Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.
- Maximum Observed Plasma Concentration (Cmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
- Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
- Time to Cmax (Tmax) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
- Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110 [ Time Frame: 24 hours post-morning dose on Day 28 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.
AUC (0-24) was computed using the linear trapezoidal method.
| Enrollment: | 48 |
| Study Start Date: | February 2011 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04620110 |
Drug: PF-04620110
5 mg of PF-04620110 given once daily
Drug: PF-04620110
2.5 mg of PF-04620110 given twice daily
|
| Placebo Comparator: placebo |
Drug: Placebo
Matching placebo giving for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298518
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Chula Vista, California, United States, 91911 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| DeLand, Florida, United States, 32720 | |
| Pfizer Investigational Site | |
| Miami Gardens, Florida, United States, 33169 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01298518 History of Changes |
| Other Study ID Numbers: | B0961007 |
| Study First Received: | January 28, 2011 |
| Results First Received: | October 5, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
multiple dose study in type 2 diabetes patients |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013