Status:
UNKNOWN
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
Lead Sponsor:
ikfe-CRO GmbH
Collaborating Sponsors:
IKFE Institute for Clinical Research and Development
Conditions:
Insulin-requiring Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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: ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01500850
Start Date
October 1 2011
End Date
October 1 2012
Last Update
December 29 2011
Active Locations (1)
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1
ikfe GmbH
Mainz, Rhineland-Palatinate, Germany, 55116