Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients – Investigation on Postprandial Excursions of Proinsulin and PAI-1 Levels

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2009-015993-37-DE
• Lead Sponsor: Institut für Klinische Forschung und Entwicklung (ikfe) GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-29
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
1.4.1.4.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

3.Age of 40-75 years inclusively
4.BMI between 20 and 35 kg/m2 inclusively
5.Patient informed consent

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

Exclusion Criteria

1.Exclusion criteria – applicable for T2DM group only:
1.1.Type 1 diabetes mellitus
1.2.1.2.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)

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified