Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ikfe-CRO GmbH
• Collaborator: IKFE Institute for Clinical Research and Development
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Give written informed consent.

• Patient consents that his/her family physician/diabetologist will be informed of trial participation

• Type-2 diabetes mellitus ≥ 1 year of diagnosis (male and female)

• Experienced in self blood glucose measurement for ≥ 3 months.

• HbA1c ≤ 9% and >6,5%

• BMI > 30 kg/m²

• Age ≥ 18 years

• Waist circumference > 88 cm (female) and > 102 cm (male)

• NPH insulin treatment plus 1 or 2 OAD (except TZD)

Exclusion Criteria:

• History of drug or alcohol abuse within the last five years prior to screening

• Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures

• History of severe or multiple allergies

• Treatment with any other investigational drug within 3 months prior to screening

• Progressive fatal disease

• History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and >1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator

• Pregnant or lactating women

• 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 vasectomized partner

• Treatment with GLP1-analog or Thiazolidinediones (TZD)

• hsCRP > 10 mg/l (by rapid test at screening visit).

• Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study

• Type 1 Diabetes mellitus

• Patients already treated with intensified conventional insulin therapy.