Investigation of a switch from Insulin Therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus

ikfe GmbH0 个研究点开始时间: 2009年11月16日最近更新: 2013年6月3日

适应症

试验速览

暂无简介。

•-Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic)
•-HbA1c < 7.5 %
•-Age: 18-80 years inclusively
•-Duration of insulin therapy > 1 year
•-Insulin dose < 120 IU/day
•-Fasting C-peptide > 0.6 ng/l
•-Fasting glucose = 210 mg/dl
•-Full legal, mental and physical ability to give informed consent
•-Patient consent that the general physician will be informed of trial participation
•- Experience ion self measurement of blood glucose <1 year
•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

•-Type 1 Diabetes mellitus
•-History of drug or alcohol abuse within the last five years prior to screening
•-History of severe or multiple allergies
•-Progressive fatal disease
•-History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
•-renal insufficiency or history of significant renal diseases (creatinine clearance lower than 60ml/min determined using the Cockroft-Goult equation)
•-Contra-indications for study drugs including contraindications for the rescue drugs
•-Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
•-Pregnancy or breast feeding
•-Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
•-Treatment with any other investigational drug within 3 months prior to screening
•-Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

发起方

ikfe GmbH