PER-119-10已完成未知
EFFICACY AND SAFETY OF INTENSIVE INSULIN THERAPY WITH INSULIN GLULISINE IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH BASAL INSULIN AND ORAL GLUCOSE-LOWERING DRUGS
sanofi-aventis Recherche & Development,0 个研究点目标入组 20 人开始时间: 2011年2月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 18 至 75（—）
- 性别
- All
入选标准
- •Uncontrolled type 2 diabetes mellitus defined as a HbA1c level between 7.5% and 10% evaluated in the previous 6 months.
- •Male or female patients 18-75 years old
- •Body Mass Index (BMI) between 25 and 40 kg / m ^ 2
- •Currently treated with basal insulin (NPH, insulin zinc or insulin detemir), plus at least 1g of metformin per day and another OGLD, if present, for at least 3 months
- •Signed informed consent obtained prior to any study procedure
排除标准
- •Type 1 diabetes mellitus
- •Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months prior to admission to the study or any other unstable (rapid progression) retinopathy that may require photocoagulation or surgery during the study (confirmed by a fund of eye performed in the previous 2 years)
- •Cardiovascular, hepatic, neurological, endocrine or other clinically relevant major disease that makes it difficult to implement the protocol or interpretation of the study results.
- •History of liver function damage defined as Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) greater than three times the upper limit of normal.
- •History of renal function damage defined as serum creatinine> 135 pmol / l in men and> 110 pmoI / 1 in women
- •History of drug or alcohol abuse
- •Patients with DMT2 treated exclusively with OGLD
- •Patients with DMT2 treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- •Previous treatment with insulin glulisine
- •Concomitant treatment with thiazolidinediones, exenatide or pramlintide
- •Systemic treatment with corticosteroids within 3 months prior to admission to the study
- •Treatment with any product under investigation within 2 months prior to admission to the study
- •History of hypersensitivity to study medications or medications with similar chemical structure
- •Presence of any mental condition that, in the opinion of the researcher, indicates that participation in the study is not in the best interest of the patient
- •Presence of geographical or social conditions that restrict or limit patient participation for the duration of the study
- •Pregnant or breastfeeding women
- •Women of reproductive age not protected by an effective contraceptive method
研究者
相似试验
已完成
不适用
Intensive versus conventional insulin therapy for inpatient medical patients [Insulinoterapia intensificada versus terapia habitual en pacientes hospitalizados por patología médica]HyperglycaemiaSigns and SymptomsElevated blood glucose levelISRCTN55845280ational Fund of Investigation and Development in Health (Fondo nacional de investigación y desarrollo en salud [FONIS]) (Chile)250
进行中（未招募）
1 期
A research study to compare a new weekly insulin, insulin icodec used with DoseGuide App, and daily insulins in people with type 2 diabetes who have not used insulin beforeDiabetes Mellitus, Type 2EUCTR2020-000476-38-DEovo Nordisk A/S1,096
进行中（未招募）
1 期
A research study to compare a new weekly insulin, insulin icodec used with DoseGuide App, and daily insulins in people with type 2 diabetes who have not used insulin beforeMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-000476-38-HUovo Nordisk A/S1,096
进行中（未招募）
1 期
A research study to compare a new weekly insulin, insulin icodec used with DoseGuide App, and daily insulins in people with type 2 diabetes who have not used insulin beforeMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2020-000476-38-PLovo Nordisk A/S1,096
进行中（未招募）
1 期
A research study to compare a new weekly insulin, insulin icodec used with DoseGuide App, and daily insulins in people with type 2 diabetes who have not used insulin beforeDiabetes Mellitus, Type 2EUCTR2020-000476-38-GRovo Nordisk A/S1,096