Type 2 Diabetes Mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: MK-0893
Product Code: MK-0893
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0893
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceut
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Patient has T2DM. b. Patient is =21 and =70 years of age on day of signing the informed consent form. c. Patient is either • Not on oral antihyperglycemic medications for at least 10 weeks, with an HbA1c of =7.0% and =11.0%, OR • On a single oral antihyperglycemic medication (but not on a PPAR-? agonist), with an HbA1c of =6.5% and =10.0%, OR • On a low-dose combination oral antihyperglycemic medication at a dose less than or equal to 50% of the maximum recommended dose of both components, with an HbA1c of =6.5% and =10.0%. d. Patient is a male, or a female who is 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 (2 barrier methods) or abstain from heterosexual activity throughout the study starting with Visit 1/ Screening and for 28 days after the last dose of study medication. Note: Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy. See Appendix 6.13 for details. e. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving informed written consent. At Visit 3/Week -2 f. Patient has a HbA1c of =7.0% and =11.0%. At Visit 4/Day -1/Randomization g. Patient has = 85% compliance with placebo treatment during the single-blind run-in as measured by site-performed tablet count. 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
Exclusion criteria
Exclusion criteria: a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. - OR - Patient is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide 150 mm Hg or diastolic blood pressure of >85 mm Hg. o. Patient has severe peripheral vascular disease, active liver disease, or active nephropathy p. Patient is HIV positive (as assessed by medical history). q. Patient has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). r. Patient is under treatment for hyperthyroidism. s. Patient has a history of malignancy. Exception: (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 the 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, lymphoma, malignant 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. t. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. u. Patient does not agree to abstain from alcohol for 48 hours prior to each clinic visit. v. Patient has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study. w. Patient is pregnant, has a positi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of treatment with a range of doses of MK-0893 compared to placebo on fasting plasma glucose after 12 weeks.;Secondary Objective: To assess the safety and tolerability of MK-0893;Primary end point(s): fasting plasma glucose, HbA1c, safety | — |
Countries
Austria, Germany, Hungary
Outcome results
None listed