A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-ArmClinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea inPatients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on MetforminTherapy - MK-0941 Compared to Glimepiride as Add-on Therapy to Metformi
- Conditions
- Type 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2008-005616-40-SE
- Lead Sponsor
- Merck Sharp & Dohme (Sweden) AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 168
Patient has type 2 diabetes mellitus (T2DM).
Patient is =18 and =70 years of age on day of signing informed consent.
Patient has a body mass index (BMI) >20 kg/m2 and <43 kg/m2.
Patient is in one of the following categories:
aPatient is currently on single oral AHA and has an A1C =7.5% and =11.0%.
OR
bPatient is on low-dose dual oral AHA combination therapy (i.e., =50% maximum labeled dose of each agent) and has an A1C =7.0% and =10.5%.
Patient is a male, or female unlikely to conceive
Patient has an FPG =140 mg/dL (7.77 mmol/L) and =260 mg/dL (14.43 mmol/L).
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
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 <0.7 ng/mL (0.23 nmol/L).
Patient has a history of severe hypoglycemia defined as two or more episodes during his/her lifetime or one episode within the past year that resulted in hypoglycemic seizures and/or cerebral impairment (e.g., coma, severe confusion, etc.) or patient has had hypoglycemia unawareness (i.e., fingerstick glucose <50 mg/dL [2.8 mmol/L] without symptoms) within the past 3 months.
Patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication
Patient has received treatment with an investigational drug within the prior 3 months or is currently participating or planning to participate in another clinical trial during the study or for one month after completing the study.
Patient is on or likely to require treatment with warfarin or warfarin-like anticoagulants, digoxin, or any other medication with a narrow therapeutic index during the study (refer to Appendix 6.1).
Patient is on or likely to require treatment with pharmacologic doses of corticosteroids
Patient has undergone a surgical procedure within 30 days prior to signing informed consent or has planned major surgery during the study.
Patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 6 months: Acute coronary syndrome, coronary artery intervention or PTCA, stroke or transient ischemic neurological disorder.
Patient has NYHA (New York Heart Association) Class II-IV cardiac status (refer to Appendix 6.2) or has severe peripheral vascular disease (e.g., manifested by claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require intervention such as with bypass or angioplasty).
Patient has poorly controlled hypertension defined as systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg and is not considered likely to be under these limits by Visit 4/Day -1 with an adjustment in antihypertensive regimen.
Patient has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), cirrhosis, or symptomatic gallbladder disease.
Patient is HIV positive (as assessed by medical history).
Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Patient is currently treated for hyperthyroidism with anti-thyroid medication or radioactive iodine.
Patient has a history of malignancy =5 years prior to signing informed consent, or >5 years without documentation of remission/cure.
Patient is being treated with the following glaucoma medications (or anticipated to be treated with during the study): ecothiophate, pilocarpine, or carbachol.
Patient is allergic to ophthalmologic dilation medications (i.e., cyclophenylate, phenylephrine).
Patient has had, or is anticipated to have, intraocular surgery (incisional surgery) within the past 6 months
Patient has had ocular herpes, uveitis, or iritis within the past 3 months
Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the past year) of drug or increase
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