E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
After 6 weeks of treatment, to assess the effect of the addition of MK 0941 compared with the addition of glimepiride on 24-hour weighted mean glucose (24-hour WMG). |
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E.2.2 | Secondary objectives of the trial |
Exploratory objectives : (1) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on 2-hour post-meal glucose (PMG) and fasting plasma glucose (FPG) (2) After 6 weeks of treatment, to assess the rate of hypoglycemia with the addition of MK-0941. (3) After 6 weeks of treatment, to assess the effect of the addition of MK 0941 on body weight.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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: a Patient is currently on single oral AHA and has an A1C ≥7.5% and ≤11.0%. OR b Patient 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).
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E.4 | Principal exclusion criteria |
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 increased alcohol consumption. Patient is pregnant, has a positive urine pregnancy test at any prestudy visit, is expecting to conceive within the projected duration of the study, or is breast-feeding. Patient has a history of intolerance or hypersensitivity to metformin Patient has known allergy or intolerance to ingredients of the meals provided during the domicile visits. Patient intends to donate blood products during the duration of the study. atient has poor mental function or any other reason to expect that the patient may have difficulty in complying with the requirements of the study such as Self Monitoring Blood Glucose (SMBG) or availability for telephone calls from the investigational site to discuss study drug titration, keeping study appointments, or planning to relocate during the study. Patient has a history or current evidence of any condition, therapy, lab abnormality which might pose a risk to the patient, confound the results of the study, or has any other circumstance which makes participation not in the patient’s best interest or might interfere with the patient's participation for the full duration of the study. Patient has a QTc interval >480 ms or has another clinically significant ECG abnormality Patient has pseudoexfoliation of the lens capsule in both eyes.
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E.5 End points |
E.5.1 | Primary end point(s) |
24-hour weighted mean glucose |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |