Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

Insulin-requiring Type 2 Diabetes Mellitus Clinical Trial

Official title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.

Status Recruiting

Clinical Trial Summary

The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.

Clinical Trial Description

• Phase IV

• Indication: Diabetes mellitus Type 2

• Primary objective:

To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.

• Secondary objectives: To evaluate changes in the parameters

• insulin,

• glucose,

• intact proinsulin (after a glucose challenge),

• hsCRP,

• adiponectin,

• MMP-9,

• HbA1c,

• weight

after 24 weeks of treatment.

To investigate the changes of

• glucose,

• intact proinsulin,

• hsCRP,

• adiponectin,

• HbA1c

• weight

between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).

To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).

-Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment)

-Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment.

• Weight

• hsCRP

• Adiponectin

• MMP-9

• OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks

• HOMA-IR score

• HbA1c

Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:

• Weight

• hsCRP

• Adiponectin

• Fasting intact Proinsulin

• Glucose

• HbA1c

• Safety Variables:

• Adverse Events

• Hypoglycaemic events

Medication/Dosage:

Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)

-Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months.

Design:

This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin-requiring Type 2 Diabetes Mellitus

• NCT number: NCT01500850
• Study type: Interventional
• Source: ikfe-CRO GmbH
• Contact: Andreas Pfützner, Professor
• Phone: 00496131-57636-0
• Email: andreasp@ikfe.de
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2011
• Completion date: October 2012