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

NCT01206712 | Completed

• 1 other identifier: SAN-FORST-001
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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 volunteers on ß-cell function after the uptake of a standardized meal.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2; insulin glargine; Metformin

Outcome Measures

Primary Outcomes (1)

• Investigation of ß-cell function via comparison of AUC0-300 minutes of intact Proinsulin in T2DM patients treated with LANTUS + Metformin (MET) vs. T2DM patients treated with Sulfonylurea (SU) + Metformin

  Comparison of AUC0-300 min \[intact Proinsulin\] between T2DM patients treated with LANTUS + Metformin and T2DM patients treated with Sulfonylurea + MET after uptake of standardized meal

  0-300 minutes after standardized meal

Secondary Outcomes (1)

• Investigation of insulin, intact proinsulin, glucose and PAI-1 levels over a 5 h period after uptake of a standardized meal comparing four different population groups

  0-300 minutes after standardized meal

Study Arms (4)

T2DM patients treated with LANTUS + MET

T2DM patients treated with LANTUS + Metformin(MET) in their routine antidiabetic therapy. These patients do not receive any study specific medication.

T2DM patients treated with SU + MET

T2DM patients treated with Sulfonylurea (SU) + Metformin(MET)in their routine antidiabetic therapy. These patients do not receive any study specific medication.

T2DM patients treated with DPP-4 + MET

T2DM patients treated with Dipeptidylpeptidase 4 inhibitors (DPP-4) + Metformin(MET) in their routine antidiabetic therapy. These patients do not receive any study specific medication.

Healthy subjects

healthy volunteres who do not receive any antidiabetic medication in their routine therapie.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Group 1 (n=20): Healthy subjects * Group 2 (n=20): T2DM patients treated with continuous SU + MET therapy as individually prescriped by the primary care physicians * Group 3 (n=20): T2DM patients treated with continuous LANTUS + MET therapy as individually prescriped by the primary care physicians * Group 4 (n=20): T2DM patients treated with continuous DPP-4 + MET therapy as individually prescriped by the primary care physicians

You may qualify if:

• 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
• Fasting blood glucose £ 100 mg/dl (5.6 mmol/l) 2.2. Oral Glucose Tolerance Test (OGTT) revealed no IGT or DM
• Age of 40-75 years inclusively
• BMI between 20 and 35 kg/m2 inclusively
• Patient informed consent

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• ikfe-CRO GmbH: lead
• Sanofi: collaborator
• IKFE Institute for Clinical Research and Development: collaborator

Study Sites (1)

IKFE Institute for Clinical Research and Development

Mainz, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas Forst, Prof. MD

  IKFE Institute for Clinical Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 22, 2010

Record last verified: 2010-09

Locations

DE (1)