ISRCTN51125379已完成1 期
Treating To Target in Type 2 diabetes
ovo Nordisk Limited (UK)0 个研究点目标入组 700 人开始时间: 2004年9月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 06/07/2007:
- •1. Informed consent
- •2. People with type 2 diabetes for at least 12 months who are insulin naive
- •3. On maximally tolerated metformin and sulphonylurea therapy for at least four months
- •4. Males and females, aged 18 years or more
- •5. Body mass index of 40.0 kg/m^2 or less
- •6. HbA1c in the range 7.0 to 10.0% inclusive
- •7. Able and willing to use insulin injections and perform self-monitoring of plasma glucose for the entire trial period
- •Previous inclusion criteria:
- •1. 700 subjects with type 2 diabetes
- •2. Males and females
- •3. Aged 18 years or over
- •4. Body mass index (BMI) less than or equal to 40kg/m^2 currently treated with oral antidiabetic drugs (OADs) (metformin and/or a sulphonylurea) and with an HbA1c in the range 7.0% to 10.0% inclusive
排除标准
- •Current exclusion criteria as of 06/07/2007:
- •1. Current or previous treatment with thiazolidinediones within the last six months
- •2. Current or previous treatment with an alpha-glucosidase inhibitor, repaglinide or nateglinide within the past 30 days
- •3. Oral Antidiabetic (OAD) treatment with three or more OADs within the last six months
- •4. Diabetes other than type 2 diabetes mellitus
- •5. Known sight-threatening retinopathy as judged by the investigator
- •6. Plasma creatinine 130 micromoles/l or more
- •7. Cardiac disease defined as:
- •7.1. Unstable angina pectoris within the last six months
- •7.2. Myocardial infarction (MI) within last six months
- •7.3. Congestive heart failure New York Heart Association (NYHA) class III and IV
- •8. Evidence of hepatic disease as determined by alanine aminotransferase (ALT) values of twice the upper limit of normal or more
- •9. Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
- •10. Anticipated change in dose of concomitant medication, which may interfere with glucose regulation, such as monoamine oxidase inhibitors (MAOI), beta-adrenergic agents, anabolic steroids or systemic glucocorticoids
- •11. Uncontrolled hypertension with systolic blood pressure repeatedly 180 mmHg or more, or diastolic blood pressure 105 mmHg or more
- •12. Known or suspected allergy to trial products or related products
- •13. Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or the evaluation of results
- •14. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- •15. Pregnant or planning to become pregnant within the next 36 months, breastfeeding, or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods.
- •16. Receipt of any investigational trial drug within three months prior to participation in this trial
- •17. Subjects previously screened for participation or having already participated in this trial
研究者
相似试验
进行中（未招募）
1 期
The DIAMOND for the Treatment of Type 2 Diabetes: Can Blood Triglycerides level be the predictor for therapy efficiency?Diabetes type 2 not controlled by oral medication.EUCTR2013-001003-36-ATMetacure Ltd.45
进行中（未招募）
不适用
4T studyTreating to Target in Type 2 DiabetesA 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin versus a Twice Daily Insulin Mixture versus a Meal-time Rapid-Acting Insulin in Subjects with Type 2 Diabetes Inadequately Controlled on Therapy with Oral Agents, and Assessing the Requirement for more Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, their Efficacy and DurabilityType 2 DiabetesEUCTR2004-000514-38-IEovo Nordisk Pharmaceuticals Ltd700
招募中
不适用
Clinical Research of Treatment of Type 2 Diabetes With Jianpi Huazhuo MassageType 2 DiabetesITMCTR2000003193anjing University of Chinese Medicine
已完成
3 期
Improved treatment of type 2 diabetes mellitus by improving the splenic functions and gastro intestinal tract using naturally occurring bioactive compoundsSplenic and gastro intestinal disorder in Type 2 Diabetes Mellitusgastrointestinal disorderMetabolic diseasesMetabolic and Endocrine - DiabetesDiabetes mellitusACTRN12614000007639guyen Van Toan94
进行中（未招募）
1 期
Individually tailored treatment in type 2 diabetesType 2 diabetesMedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-004883-23-DKHenning Beck-Nielsen