Type 2 Diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Lantus
Product Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337951
Concentration unit: U/ml unit(s)/millilitre
Concentratio
Sponsors
Institut für Klinische Forschung und Entwicklung (ikfe) GmbH
Eligibility
Sex/Gender
All
Inclusion 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. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the ß-cell function via comparison of the area under the curve over the time period of 0 to 300 minutes (AUC0-300) of intact Proinsulin between T2DM patients treated with LANTUS in combination with MET and T2DM patients treated with SU in combination with MET after uptake of a standardized meal.;Secondary Objective: Comparison of AUC0-300 of intact proinsulin after a standardized meal: - LANTUS + MET patients vs. healthy subjects - LANTUS + MET patients vs. DPP-4 + MET patients - DPP-4 + MET patients vs. healthy subjects - DPP-4 + MET patients vs. SU + MET patients - SU + MET patients vs. healthy subjects Comparison of AUC0-300 for insulin, AUC0-300 and AUC0-180 for glucose (BG) after the standardized meal : - LANTUS + MET patients vs. healthy subjects - LANTUS + MET patients vs. SU + MET patients - LANTUS + MET patients vs. DPP-4 + MET patients - DPP-4 + MET patients vs. healthy subjects - DPP-4 + MET patients vs. SU + MET patients - SU + MET patients vs. healthy subjects Comparison of the mean maximum levels of intact proinsulin, insulin and BG between the 4 groups, comparison of the PAI-1 level excursion at the time points 0, 150 and 300 min between the 4 groups after the meal. Also the change in insulin/ intact proinsulin ratio in between the 4 groups will be analyzed.;Primary end point(s): Comparison of AUC0-300 min [intact Proinsulin] between T2DM patients treated with LANTUS + METFORMIN (MET) and T2DM patients treated with SULFONYLUREA (SU) + MET after uptake of standardized meal | — |
Countries
Germany
Outcome results
None listed