PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON METFORMIN TREATMENT MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: PF-00734200
Pharmaceutical Form: Tablet
CAS Number: 869490-23-3
Other descriptive name: Pyrrolidine,3,3-difluoro-1- [[(2S,4S)-4-[4-(2-pyrimidinyl)-1-piperazinyl] -2-pyrrolidinyl]carbonyl
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women between the ages of >18 and 22.0 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of Type 1 diabetes mellitus or secondary forms of diabetes. 2. History of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack within 6 months of Screening. 3. Uncontrolled hypertension as determined by the Principal Investigator 4. Screening 12-lead ECG demonstrating a QTc >470 msec, confirmed by a single repeat if deemed necessary. 5. Any prior history of malignancy with the exception of: a. Basal cell carcinoma of the skin; or b. Squamous cell carcinoma of the skin that has been cancer free for >5 years; or c. Other malignancies (regardless of site) that have been cancer free for >10 years 6. History of major depressive disorder within 2 years from Screening. 7. History of abuse of alcohol and/or any other illicit drug use or dependence within 6 months of Screening. As a general rule alcohol intake should not exceed 21 drinks per week for men and 14 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor). 8. Any medical condition possible affecting study drug absorption (ex, gastrectomy). 9. Women who are pregnant, planning to become pregnant or nursing 10. Subjects with a known hypersensitivity or intolerance to any DPP-4 inhibitor 11. Subjects who have previously been enrolled in a trial with PF-00734200. 12. Screening C-peptide 270 mg/dL, confirmed by a single repeat following counseling on exercise and diet. 14. Fasting serum triglyceride >500 mg/dL at Screening, confirmed by a single repeat if deemed necessary. 15. Subjects with uncontrolled thyroid disease at Screening 16. Serum creatinine or creatinine clearance at Screening which would be a contraindication to metformin treatment according to the country product label. For example, in the United States, a serum creatinine >1.5 mg/dL for men and >1.4 mg/dL for women. 17. Active hepatobiliary disease or an AST or ALT >2-x the upper limit of the reference range (ULRR) at Screening, or a TBili >1.5-x the ULRR at Screening. 18. Unexplained creatine kinase >3-x ULRR at Screening (eg, not due to recent trauma, heavy exercise, intramuscular injection, etc). Subjects with a reason for the creatine kinase elevation may have the value repeated once during Screening. A repeat creatine kinase >3-x ULRR is exclusionary. 19. The following therapeutic agents are prohibited for the duration of the study. These medications are not to be used from the time of the start of the placebo run-in period to the completion of the study. • Chronic oral or parenteral prednisone, dexamethasone, methylprednisolone or hydrocortisone at any dose. Intercurrent steroid treatment may be administered if treatment does not exceed one week. Note that inhaled and topical corticosteroids are permitted. • Orlistat, sibutramine, rimonabant, or other medications approved for weight loss • Anti-psychotic medication including olanzapine, risperidone 20. The following therapeutic agents are prohibited for the duration of the study. These medications are not to be used from the time of Screening Visit S1 through the completion of the study. • Insulin • Exenatide or any GLP-1 analogue • Bromocriptine • Any other anti-hyperglycemic therapy with the exception of the protocol approved agents (includes the agents that subjects are allowed to wash-off from) 21. Participation in other studies within 30 days before the current study begins and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of two oral doses of PF-00734200 on change from baseline to 12 weeks in HbA1c levels in subjects with T2DM on metformin.;Secondary Objective: To evaluate the effect of two oral doses of PF-00734200 on change from baseline to 12 weeks in fasting plasma glucose in subjects with T2DM on metformin. To compare the proportion of subjects who achieve the current ADA glycemic goal of HbA1c <7%. To provide 12-week safety and tolerability data of two oral doses of PF-00734200 in subjects with T2DM on metformin.;Primary end point(s): The primary endpoint in this study is the change in HbA1c from baseline to Week 12 | — |
Countries
Poland
Outcome results
None listed