Effects Of PF-04971729 In Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01054300
First received: January 20, 2010
Last updated: April 21, 2010
Last verified: April 2010
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Purpose
This is a Phase 1 study to understand the manner in which the body responds to, as well as how the drug is handled by the body, with once vs twice daily dosing of PF-04971729 in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 Adult |
Drug: 2 mg single dose Drug: 2 mg split into twice daily Drug: 4 mg single dose Drug: 4 mg split into twice daily |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Pharmacodynamic Effect - 24hr as well as time course over intervals of 0-4, 4-8, 8-12 and 12-24hr, of urinary glucose excretion (UGE) and 24-hr mean plasma glucose, fasting plasma glucose and C-peptide [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
- Safety and Tolerability - adverse events, serious adverse events, clinical lab tests, vitals, 12-lead electrocardiograms [ Time Frame: 3-weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetics - Area-under-the-curve from 1st dose to last PK collection in each period (AUClast), maximum plasma concentration (Cmax), and time of Cmax (Tmax) [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
- Pharmacokinetic (PK) - pharmacodynamics (PD) - relationship, if any, between PF-04971729 PK and selected PD endpoints [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | February 2010 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 2 mg single dose |
Drug: 2 mg single dose
2mg dose (using 1mg strength tablets), administered as a single dose
|
| Experimental: 2 mg split into twice daily |
Drug: 2 mg split into twice daily
1 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
|
| Experimental: 4 mg single dose |
Drug: 4 mg single dose
4mg dose (using 1mg strength tablets), administered as a single dose
|
| Experimental: 4 mg split into twice daily |
Drug: 4 mg split into twice daily
2 mg dose (using 1 mg strength tablets) administered twice daily x 1 day
|
Detailed Description:
Phase 1 PK-PD study to understand the body's response to twice daily versus once daily dosing of PF-04971729. This study also plans to study how the body handles PF-04971729.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with type 2 diabetes, on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.
Exclusion Criteria:
- Patients with type 1 diabetes, patients with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054300
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Chula Vista, California, United States, 91911 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami Gardens, Florida, United States, 33169 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01054300 History of Changes |
| Other Study ID Numbers: | B1521007 |
| Study First Received: | January 20, 2010 |
| Last Updated: | April 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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