A 50 Week Extension to: A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK-0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - MK-0431 and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 7.0 Level: LLT Classification code 10045242
- Registration Number
- EUCTR2005-000407-34-GB
- Lead Sponsor
- Merck Sharp & Dohme Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 900
036 BASE STUDY:
Patients who meet the criteria listed below will be recruited for enrollment into the study. All laboratory measurements are to be performed after an overnight fast =12 hours in duration.
a.Patient has type 2 diabetes mellitus (T2DM).
b.Patient is =18 and =78 years of age.
c.Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
d.Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period.
e.Patient is a male, or a female who is highly unlikely to conceive, as indicated by at least one yes” answer to the following questions:
1)Patient is a male.
2)Patient is a surgically sterilized female.
3)Patient is a postmenopausal female =45 years of age with >2 years since last menses.
4)Patient is a non-sterilized premenopausal female and agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication. Refer to Section I.E.12.a. for description of acceptable methods of contraception.
f.Patient meets one of the following criteria as indicated by a yes” answer to one of the following:
1)Patient is currently not on an antihyperglycemic agent (off therapy for =8 weeks) and has a Visit 1/Screening Visit HbA1c =7.5% and =11%.
OR
Patient is in 1 of the following 3 categories AND based upon review of the patient’s current diet, medical regimen, and Visit 1/Screening Visit HbA1c, patient is considered by the investigator to be likely to meet Visit 3 inclusion criterion of HbA1c =7.5% to =11% with diet/exercise counseling:
2)Patient is currently not on an antihyperglycemic agent (off therapy for =8 weeks) and has a Visit 1/Screening Visit HbA1c >11%.
3)Patient is currently on antihyperglycemic agent monotherapy or dual oral combination therapy and has a Visit 1/Screening Visit HbA1c =7% and =10%.
4)Patient is currently on dual oral combination therapy (which contains at least one agent dosed at >50% maximal labeled dose), has Visit 1/Screening Visit HbA1c =6.5% and <7%, and has been approved by the Merck clinical monitor.
NOTE: Patients currently not on an antihyperglycemic agent, but off therapy for <8 weeks, may be enrolled following discussion with and approval by the Merck Clinical Monitor.
g.HbA1c =7.5% and =11% measured at Visit 3. NOTE: Once a patient has initiated placebo run-in at Visit 3, if the Visit 3 HbA1c is not within the Visit 3 HbA1c inclusion criterion, a single repeat measurement may be performed at the discretion of the investigator. If repeat value meets Visit 3 HbA1c inclusion criterion, patient may continue in study.
h.Patient has =75% compliance (as measured by tablet count) with placebo treatment during run-in.
036 EXTENSION STUDY:
All laboratory measurements are to be performed after an overnight fast =12 hours in duration.
At
036 BASE STUDY
See the BASE STUDY protocol for comprehensive list and additional clarification.
a. Patient has a history of type 1 diabetes or ketoacidosis.
b. Patient required insulin within the prior 8 weeks.
c. Patient has an hypersensitivity contraindication to biguanide medication.
d. Patient has a serum ALT or AST >2.0-fold the Upper Limit of Normal. Note: Patients whose serum ALT or AST exceeds this limit may be retested one time if the investigator does not believe the value reflects the patient’s clinical status.
e. Serum creatinine 123.8 µmol/L in men and 114.9 µmol/L in women or estimated creatinine clearance (using Cockcroft-Gault formula) <60 mL/min.
f. Patient has cirrhosis or active liver disease or active nephropathy or chronic progressive neuromuscular disorder or any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
g. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months or has any of the following disorders within the past 6 months: 1) Acute coronary syndrome. 2). Coronary artery intervention. 3) Stroke or transient ischemic neurological disorder. 4) Congestive heart failure treated with pharmacologic therapy. h. Patient is HIV positive.
i. Patient has a clinically important hematological disorder.
j. Patient has a history of malignancy. Exceptions: 1) patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate; 2) patients with other malignancies which have been successfully treated =5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening; and 3) patients who, in the joint opinion of homa, malthe Merck medical monitor and investigator, are highly unlikely to sustain a recurrence during the duration of the study. However, patients with a history of leukemia, lympignant melanoma, myeloproliferative disease, or renal cell carcinoma are ineligible for the study regardless of the time since treatment, and in such cases, no exceptions will apply.
k. Patient has a history of alcohol or drug abuse within the past year 3 years.
l. Patient has a fasting plasma glucose consistently >270 mg/dL (14.99 mmol/L) and is not considered likely to improve glycemic control with diet and exercise counseling.
036 EXTENSION STUDY
At Visit 14
a.Patient has developed any medical condition or disorder that, in the opinion of the investigator or Merck Clinical Monitor, might pose a risk to the patient or would make the use of metformin contraindicated based upon the product label in that country (refer to Appendix 11).
b.Patient is on or likely to require an excluded medication (ie. Non-study antihyperglycemic medication, immunosuppressive/immunomodulating agent, etc. (See Appendix 1).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method