NCT01500850

Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ikfe-CRO GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Insulin-requiring Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	nph insulin	Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
DRUG	human insulin	Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. human insulin: bolus injections before each main meal
DRUG	Insulin Glargine	Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
DRUG	Insulin glulisine	Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL. Insulin glulisine: bolus injections before each main meal

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-12-29
• Last updated: 2011-12-29

Locations

1 site across 1 country: Germany