PER-068-08已完成未知
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
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2008年8月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21 至 70（—）
入选标准
- •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.
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
A dose-ranging clinical study to determine the range of grass pollen allergen (gpCPT+) concentrations to be used in a conjunctival provocation test to grade moderate to severe hay fever in patients suffering from allergic inflammation of the conjunctiva which is caused by grass pollen allergens.This clinical trial aims to evaluate a conjunctival provocation test (CPT) with the IMP gpCPT+ for the assessment and grading of grass pollen allergic rhinoconjunctivitis. Thus, a diagnostic solution will be tested and not medical condition or disease. Patients will be included in this trial who are suffering from grass pollen allergic rhinoconjunctivitis.MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853EUCTR2017-004616-19-DEASIT biotech S.A.76
尚未招募
不适用
A clinical study to determine the optimal dose of WIN-1001X by evaluating its efficacy and safety in patients with early Parkinson’s diseaseDiseases of the nervous systemKCT0004536Medihelpline188
已完成
1 期
Dose-escalation safety of novel fungal beta-glucanshealthy adult individualsbeta-GlucansPolysaccharidesOligosaccharidesFungiClinical TrialSafetyDietary SupplementsDose-escalation studyTCTR20240705004Institute of Nutrition, Mahidol University18
进行中（未招募）
1 期
A research study to learn about the effects of IMB-1018972, to try and help your heart cell use energy more efficiently, to find the best dose, and to see how safe it is. This is for patients who may be at risk for a heart condition known as diabetic cardiomyopathy (DbCM) as a complication of a type 2 diabetes mellitus (T2DM).EUCTR2020-003280-26-GBImbria Pharmaceuticals, Inc.36
已完成
1 期
Clinical trial for identification of safety dose of coffee cherry concentrate in healthy volunteerssafety studyhealthy volunteersconsumer product safetydose, maximum toleratedbeverages and foodcoffeeTCTR20220927004Mivana Company Limited18