Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients

Launched by IKFE-CRO GMBH · Sep 21, 2010

Keywords

ClinConnect Summary

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 been the topic of interest in numerous preclinical and clinical studies in patients with type 2 diabetes mellitus. Intact proinsulin was confirmed as a marker of functional beta cell failure and as a predictor of increased beta cell loss due to apoptosis and/or diminished neogenesis.

A number of population based studies showed that intact proinsulin is a strong predictor of coronary heart diseas...

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Eligibility criteria

• Inclusion Criteria:
• 1. Inclusion criteria - applicable for T2DM group only:
• • 1.1. 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
• 2. Inclusion criteria - applicable for healthy subject only:
• • 2.1. 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:
• • 3. Age of 40-75 years inclusively
• • 4. BMI between 20 and 35 kg/m2 inclusively
• • 5. Patient informed consent
• Exclusion Criteria:
• 1. Exclusion criteria - applicable for T2DM group only:
• • 1.1. 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
• 2. Exclusion criteria - applicable for healthy subject only:
• • 2.1. 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:
• • 3. History of drug or alcohol abuse within the last five years prior to screening
• • 4. History of severe or multiple allergies
• • 5. Treatment with any other investigational drug within 3 months prior to screening
• • 6. Progressive fatal disease
• • 7. Known psychiatric illness
• • 8. 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
• • 9. Pregnancy or breast feeding
• • 10. 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
• • 11. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study