Status:
COMPLETED
Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
Sanofi
IKFE Institute for Clinical Research and Development
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
Brief Summary
The purpose of this phase IV clinical trial is to investigate the effect of Insulin glargine + metformin treatment vs. sulfonylurea + metformin treatment vs. DPP-4 + metformin treatment vs. healthy vo...
Detailed Description
Type 2 diabetes mellitus is a progressive disease characterised by a steady loss of beta cell function and an increase in the proinsulin/insulin ratio. During the recent years intact proinsulin has be...
Eligibility Criteria
Inclusion
- Inclusion criteria - applicable for T2DM group only:
- 1. Type 2 diabetes mellitus 1.2. Duration of T2DM between 3 and 15 years inclusively 1.3. HbA1c up to 7.5% inclusively 1.4. Treated with LANTUS+MET (Group LANTUS+MET) or SU+MET (Group SU+MET) or DPP-4+MET (Group DPP-4+MET) respectively during the past 6 months before entering the study 1.5. Treated on a stable antidiabetic dosage during the past 3 months before entering the study
- Inclusion criteria - applicable for healthy subject only:
- 1. Fasting blood glucose £ 100 mg/dl (5.6 mmol/l) 2.2. Oral Glucose Tolerance Test (OGTT) revealed no IGT or DM
- Inclusion criteria - applicable for all subjects:
- Age of 40-75 years inclusively
- BMI between 20 and 35 kg/m2 inclusively
- Patient informed consent
Exclusion
- Exclusion criteria - applicable for T2DM group only:
- 1. Type 1 diabetes mellitus 1.2. Treatment with any other insulin than LANTUS during the past 6 months in Group LANTUS+MET or with any kind of insulin during the past 3 months in Group SU+MET or Group DPP-4+MET before entering the study 1.3. Treatment with any kind of OAD except MET during the past 6 months in Group LANTUS+MET or with any kind of OAD except MET+SU during the past 3 months in Group SU+MET or with any kind of OAD except DPP-4+SU during the past 3 months in Group DPP-4+MET before entering the study 1.4. Major micro- or macro vascular complications as judged by the investigator
- Exclusion criteria - applicable for healthy subject only:
- 1. Type 1 or type 2 diabetes mellitus (checked by oGTT) 2.2. Impaired Glucose Tolerance (IGT, checked by oGTT) 2.3. Impaired Fasting Glucose (IFG, checked by oGTT)
- Exclusion criteria - applicable for all subjects:
- History of drug or alcohol abuse within the last five years prior to screening
- History of severe or multiple allergies
- Treatment with any other investigational drug within 3 months prior to screening
- Progressive fatal disease
- Known psychiatric illness
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.1 mg/dl in women and \> 1.5 mg/dl in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- 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
- Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01206712
Start Date
November 1 2009
End Date
July 1 2010
Last Update
September 22 2010
Active Locations (1)
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1
IKFE Institute for Clinical Research and Development
Mainz, Germany, 55116