Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01475461
First received: September 15, 2011
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Placebo Drug: PF-04937319 - 3mg Drug: PF-04937319 - 20mg Drug: PF-04937319 - 50mg Drug: PF-04937319 - 100mg Drug: Sitagliptin - 100mg |
Phase 2 |
| 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 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- HbA1C - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
- Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
- 12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
- Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
- Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
| Enrollment: | 345 |
| Study Start Date: | November 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
double-dummy placebo tablets administered once-daily for 84-days
|
| Experimental: PF-04937319 - Dose 1 |
Drug: PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
|
| Experimental: PF-04937319 - Dose 2 |
Drug: PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
|
| Experimental: PF-04937319 - Dose 3 |
Drug: PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
|
| Experimental: PF-04937319 - Dose 4 |
Drug: PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
|
| Active Comparator: Sitagliptin |
Drug: Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female
Exclusion Criteria:
- patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475461
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| United States, California | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92801 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90057 | |
| Pfizer Investigational Site | |
| Spring Valley, California, United States, 91978 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Belleview, Florida, United States, 34420 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33135 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Conyers, Georgia, United States, 30094 | |
| United States, Idaho | |
| Pfizer Investigational Site | |
| Meridian, Idaho, United States, 83646 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Mount Sterling, Kentucky, United States, 40353 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Paramus, New Jersey, United States, 07652 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14609 | |
| United States, North Dakota | |
| Pfizer Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Kettering, Ohio, United States, 45429 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78756 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77081 | |
| Pfizer Investigational Site | |
| Plano, Texas, United States, 75024 | |
| Pfizer Investigational Site | |
| Sugar Land, Texas, United States, 77479 | |
| Pfizer Investigational Site | |
| Tomball, Texas, United States, 77375 | |
| Hungary | |
| Pfizer Investigational Site | |
| Balatonfured, Hungary, 8230 | |
| Pfizer Investigational Site | |
| Bekescsaba, Hungary, 5600 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1036 | |
| Pfizer Investigational Site | |
| Debrecen, Hungary, 4043 | |
| Pfizer Investigational Site | |
| Debrecen, Hungary, 4032 | |
| Pfizer Investigational Site | |
| Gyor, Hungary, 9023 | |
| Pfizer Investigational Site | |
| Polgar, Hungary, 4090 | |
| Pfizer Investigational Site | |
| Szeged, Hungary, 6720 | |
| Pfizer Investigational Site | |
| Zalaegerszeg, Hungary, 8900 | |
| India | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400 007 | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400 012 | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411001 | |
| Pfizer Investigational Site | |
| Jaipur, Rajasthan, India, 302001 | |
| Philippines | |
| Pfizer Investigational Site | |
| Cebu City, Philippines, 6000 | |
| Pfizer Investigational Site | |
| Marikina City, Philippines, 1810 | |
| Pfizer Investigational Site | |
| Pasig City, Philippines, 1605 | |
| Romania | |
| Pfizer Investigational Site | |
| Cluj-Napoca, Jud. Cluj, Romania, 400006 | |
| Pfizer Investigational Site | |
| Bucuresti, Romania, 011234 | |
| Pfizer Investigational Site | |
| Bucuresti, Romania, 020475 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 831 01 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 851 01 | |
| Pfizer Investigational Site | |
| Lucenec, Slovakia, 984 01 | |
| Pfizer Investigational Site | |
| Nitra, Slovakia, 949 01 | |
| Pfizer Investigational Site | |
| Nove Mesto nad Vahom, Slovakia, 915 01 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 080 01 | |
| Pfizer Investigational Site | |
| Trebisov, Slovakia, 075 01 | |
| Pfizer Investigational Site | |
| Trencin, Slovakia, 911 01 | |
| South Africa | |
| Pfizer Investigational Site | |
| Bloemfontein, Free State, South Africa, 9301 | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng, South Africa, 1829 | |
| Pfizer Investigational Site | |
| Midrand, Gauteng, South Africa, 1685 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0083 | |
| Pfizer Investigational Site | |
| Waverley, Gauteng, South Africa, 2090 | |
| Pfizer Investigational Site | |
| Kimberley, Northern Cape, South Africa, 8301 | |
| Pfizer Investigational Site | |
| Durban, South Africa, 4091 | |
| Pfizer Investigational Site | |
| Moloto, South Africa, 1022 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Changhua City, Taiwan, 500 | |
| Pfizer Investigational Site | |
| New Taipei City, Taiwan, 220 | |
| Pfizer Investigational Site | |
| Taichung, Taiwan, 40705 | |
| Pfizer Investigational Site | |
| Tainan, Taiwan, 710 | |
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: | NCT01475461 History of Changes |
| Other Study ID Numbers: | B1621007 |
| Study First Received: | September 15, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 2 type 2 diabetes mellitus PF-04937319 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013