An Efficacy and Tolerability Study of MK-0533 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - ND

• Conditions: Type II diabetes; MedDRA version: 9.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependent

• Registration Number: EUCTR2006-002090-47-IT
• Lead Sponsor: MERCK SHARP DOHME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

2.2 SUBJECT/PATIENT INCLUSION CRITERIA Patients must meet all of the following criteria to participate in the study: Assessed at Visit 1 1. Patient has T2DM. 2. Patient is 18 to 65 years of age; patients up to 70 years of age may be enrolled with prior approval from the IRB/ERC. 3. Patient has a BMI between 25 kg/m2 and 40 kg/m2. 4. Patient is a male, a post-menopausal female, or an oophorectomized female. Note: Post-menopausal female will be defined as >=45 years of age with absence of menses greater than 2 years. 5. Patient understands the study procedures, and agrees to participate in the study by giving written informed consent. Glycemic Entry Criteria 6. Patient is currently not on an antihyperglycemic agent for >=12 weeks and has an HbA1c >=7% and <=10%. Note: If the HbA1c value is not indicative of the patient's glycemic status, one repeat HbA1c measurement may be performed in order to determine if the patient meets this inclusion criterion. If, for any reason, more than 3 weeks elapse between Visit 1 and Visit 2, then a repeat HbA1c measurement must be performed again to confirm that the patient continues to meet the above HbA1c criteria.
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

2.3 SUBJECT/PATIENT EXCLUSION CRITERIA All laboratory measurements are to be performed after an overnight fast of at least 10 hours in duration. Please note that at Visit 3/Day 1, Visit 5/Week 4, and Visit 7/Week 12 patients will be asked to fast for an additional 4 hours during the clinic visit for collection of additional blood samples. Unless otherwise stated below, if the laboratory value is not indicative of the patient's clinical status, one repeat test may be performed. The patient may continue in the study only if the repeat value does not meet the exclusion criterion. Individuals are excluded from participation in the study if they meet any of the following criteria: At Visit 1 Glucose Metabolism and Therapy Criteria 1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. 2. Patient required antihyperglycemic therapy within the prior 12 weeks. Lipid Metabolism and Therapy Criteria 3. Patient has a fasting triglycerides (TG) level >600 mg/dL (6.8 mmol/L). Patients Requiring Specific Treatments 4. Patient requires treatment with a diuretic or any other treatment which may cause the patient not to maintain a stable fluid status or body weight. 5. Patient is taking or is likely to require treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors. Note: Use of acetaminophen or aspirin (81 mg to 325 mg) is permitted during the study 6. Patient is on a stable dose of a statin, ezetimibe, Vytorin?, lipid altering doses of natural products and/or antihypertensive therapy (including calcium channel blockers, beta-blockers, ACE inhibitors or angiotensin-II receptor blockers) for less than 4 weeks prior to screening or is anticipated to require an adjustment or initiation of lipid or antihypertensive therapy during the study. 7. Patient is taking niacin or a bile-acid binding resin within 6 weeks of Visit 1 or is taking a fibrate agent within 8 weeks of Visit 1. 8. Patient is on a weight loss program or a weight loss medication (e.g., orlistat, sibutramine or any over-the-counter diet preparation) within 8 weeks prior to screening or plans to start to a weight loss program or weight loss medication during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified