A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 12-WEEK ADMINISTRATION OF PF-00734200 TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON METFORMIN TREATMENT
- Conditions
- PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON METFORMIN TREATMENTMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2007-007588-26-PL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
1. Men and women between the ages of >18 and <80 years of age at the time of
Screening Visit 1 with a diagnosis of Type 2 diabetes mellitus in accordance with
ADA guidelines.
2. HbA1c at Screening Visit 1 based on the background diabetes medication of the
subject:
Diabetes Medication at Screening Visit 1 (S1)
Metformin monotherapy = 7.0-11.0% HbA1c
Metformin + Insulin secretagogue = 6.5-9.5%, inclusive HbA1c
Metformin + TZD = 6.5-9.5%, inclusive HbA1c
3. Body mass index (BMI) >22.0 kg/m2 and <45.0 kg/m2 at Screening Visit S1
4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 <0.8 ng/mL.
13. Screening fasting plasma glucose >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of two oral doses of PF-00734200 on change from baseline to<br>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<br>12 weeks in fasting plasma glucose in subjects with T2DM on metformin.<br><br>To compare the proportion of subjects who achieve the current ADA glycemic goal<br>of HbA1c <7%.<br><br>To provide 12-week safety and tolerability data of two oral doses of PF-00734200 in<br>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
- Secondary Outcome Measures
Name Time Method