A CLINICAL TRIAL OF DETERMINATION OF THE DOSE RANGE OF PHASE IIB / III, MULTICENTER, RANDOMIZED, IN DOUBLE BLIND, CONTROLLED WITH PLACEBO OF MK-0941 PERFORMED IN PATIENTS WITH DIABETES MELLITUS TYPE 2 AND INAPPROPRIATE GLUCEMIC CONTROL RECEIVING INSULI
- Conditions
- -E10 Insulin-dependent diabetes mellitus-E14 Unspecified diabetes mellitusInsulin-dependent diabetes mellitusUnspecified diabetes mellitusE10E14
- Registration Number
- PER-068-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient has type 2 diabetes mellitus (T2DM).
• The patient is> 21 and <70 years of age on the day of signing the informed consent.
• The patient is currently receiving LANTUS® insulin at a stable dose> 15 units / day, either alone or in combination with a metformin monotherapy at a dose> 1500 mg / day, for a minimum of 6 weeks, and has an HbA1c > 7.5% and <11.0% in Visit 1 / Selection Visit
• The patient is in 1 of the following 4 categories and, based on the review of the patient´s current diet, medical regimen, and HbA1c at Visit 1 / Screening Visit, the researcher considers that the patient probably meets the criteria of inclusion of Visit 4 / Week -2 of HbA1c> 7.5% and <11.0% after receiving LANTUS® during a stable dose period of 6 weeks (at a dose> 15 units / day)
• The patient has a body mass index (BMI)> 20 kg / m2 and <43 kg / m2.
• The patient is a man, or a woman who is highly unlikely to conceive
• The patient has HbA1c> 7.5% and <11.0%.
• The patient has> 85% compliance during the simple blind transition period as measured by the count of tablets carried out on the site.
• The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. Or the patient possibly suffers from type 1 diabetes according to the researcher´s evaluation confirmed with a peptide level C <0.7 ng / mL (<0.23 nmol / L).
• Note: Only patients who possibly suffer from type 1 diabetes according to the investigator´s evaluation should measure the C-peptide in Visit 1 / Screening Visit.
• The patient received more than 1 week of dose administration of a therapy with TZD (eg, pioglitazone or rosiglitazone) or injectable therapy based on incretin (eg, Byetta®) within the previous 8 weeks.
• The patient has had two or more episodes during his lifetime or more than one episode within the past year that resulted in hypoglycemic seizures, comas or unconsciousness.
• Hypersensitivity or contraindication to LANTUS® insulin.
• The patient is in a weight loss program and is not in the maintenance phase, or the patient is taking a weight-loss drug (eg, orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1 / Screening Visit .
• The patient has received treatment with an investigational drug within the previous 3 months or is currently participating or is planning to participate in another clinical trial.
• The patient is receiving or is likely to require treatment with warfarin or anticoagulants similar to warfarin, digoxin, or some other drug with a narrow therapeutic index (see Appendix 6.4).
• The patient is receiving or is likely to require treatment with immunosuppressive / immunomodulatory agents (eg, cyclosporine, methotrexate, etanercept) or the patient is receiving or is likely to require treatment for> 14 consecutive days or repeated courses of pharmacological doses of systemic corticosteroids (oral) , injectable / parenteral) or ocular, during the study.
• The patient has undergone surgery within 30 days prior to Visit 1 / Screening Visit or has planned major surgery.
• The patient presents new signs or symptoms of coronary heart disease or congestive heart failure, or worsening of them, within the last 3 months, or has suffered from any of the following disorders in the last 6 months: Acute coronary syndrome (for example , MI or unstable angina), coronary artery surgery (for example, CABG or PTCA), cerebrovascular accident or TIA (transient ischemic attack)
• The patient has a Class II-IV cardiac condition established by NYHA (refer to Appendix 6.5) or has a severe peripheral vascular disease (eg, manifested by claudication with minimal activity, an ischemic ulcer that does not heal, or a disease that probably requires intervention as with a bypass or angioplasty).
• The patient has a systolic blood pressure> 165 mm Hg or diastolic blood pressure> 95 mm Hg and blood pressure is not considered likely to fall below these limits at Visit 5 / Day 1 with an adjustment of the antihypertensive regimen.
• The patient suffers from chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, multiple sclerosis or polymyositis).
• The patient has nephropathy (ie, nephrotic syndrome or glomerulonephritis).
• The patient suffers from active liver disease (different from nonalcoholic hepatic steatosis), active viral hepatitis (Hepatitis B or chronic Hepatitis C) according to the evaluation of the medical history, cirrhosis, or active cholecystopathy, including primary biliary cirrhosis.
• The patient is HIV positive (based on the evaluati
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Measurement of HbA1c levels during the study.<br>Measure:Change from baseline in HbA1c in Week 14 (Phase A) and in Week 54 (Phase B).<br>Timepoints:Week 14 (Phase A) and in Week 54 (Phase B)<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurement of glucose levels 2 hours postprandial during the study<br>Measure:Change from baseline in glucose 2 hours postprandial in Week 14 (Phase A) and in Week 54 (Phase B).<br>Timepoints:Week 14 (Phase A) and in Week 54 (Phase B).<br>;<br>Outcome name:Measurement of plasma glucose levels by laboratory tests during the study.<br>Measure:Change from baseline in fasting plasma glucose (FPG) in Week 14 (Phase A) and in Week 54 (Phase B).<br>Timepoints:Week 14 (Phase A) and in Week 54 (Phase B).<br>