Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ikfe-CRO GmbH.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
IKFE Institute for Clinical Research and Development
Information provided by (Responsible Party):
ikfe-CRO GmbH
ClinicalTrials.gov Identifier:
NCT01500850
First received: December 5, 2011
Last updated: December 23, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Insulin-requiring Type 2 Diabetes Mellitus
Drug: nph insulin
Drug: human insulin
Drug: Insulin Glargine
Drug: Insulin glulisine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.

Resource links provided by NLM:


Further study details as provided by ikfe-CRO GmbH:

Primary Outcome Measures:
  • Fasting Intact Proinsulin [ Time Frame: Change from baseline at 24 weeks ] [ Designated as safety issue: No ]
    The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.


Secondary Outcome Measures:
  • Weight [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate the changes of weight after 24 weeks of treatment compared to baseline.

  • hsCRP [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of hsCRP after 24 weeks of treatment compared to baseline.

  • Adiponectin [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of adiponectin after 24 weeks of treatment compared to baseline.

  • MMP-9 [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of MMP-9 after 24 weeks of treatment compared to baseline.

  • OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes) after 24 weeks of treatment compared to baseline.

  • HOMA-IR score [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of HOMA-IR score after 24 weeks of treatment compared to baseline.

  • HbA1c [ Time Frame: Baseline and after 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of HbA1C after 24 weeks of treatment compared to baseline.

  • Weight [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of weight after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • hsCRP [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of hsCRP after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • Adiponectin [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of adiponectin after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • Fasting intact Proinsulin [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of fasting intact proinsulin after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • Glucose [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of Glucose after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • HbA1c [ Time Frame: After 12 weeks of treatment compared to baseline and to 24 weeks of treatment. ] [ Designated as safety issue: No ]
    To evaluate changes of HbA1c after 12 weeks of treatment compared to baseline and compared to 24 weeks.

  • Responder rate [ Time Frame: After 24 weeks of treatment compared to baseline. ] [ Designated as safety issue: No ]
    To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).

  • Hypoglycemic events. [ Time Frame: Baseline up to 24 weeks. ] [ Designated as safety issue: Yes ]
    Hypoglycemic events defined as blood glucose below 63 mg/dl.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NPH insulin + insulin glulisine
Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
Drug: nph insulin
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Other Name: Insuman Basal
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

Other Name: Apidra
Active Comparator: NPH insulin + human insulin
Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.
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

Other Name: Insuman Rapid
Experimental: Insulin glargine + insulin glulisine
Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
Drug: Insulin Glargine
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Other Name: Lantus
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

Other Name: Apidra
Experimental: Insulin Glargine + Human insulin
Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.
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

Other Name: Insuman Rapid
Drug: Insulin Glargine
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Other Name: Lantus

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500850

Contacts
Contact: Andreas Pfützner, Professor 00496131-57636-0 ext 20 andreasp@ikfe.de
Contact: Thomas Forst, Professor 00496131-57636-0 ext 16 thomasf@ikfe.de

Locations
Germany
ikfe GmbH Recruiting
Mainz, Rheinland-Pfalz, Germany, 55116
Contact: Thomas Forst, MD    +49(0) 6131-576 36 -40 ext 16    thomasf@ikfe.de   
Contact: Daniela Sachsenheimer, MD    +49(0) 6131-576 36 40 ext 46    danielas@ikfe.de   
Sub-Investigator: Daniela Sachsenheimer, MD         
Sub-Investigator: Stephanie Helleberg, MD         
Sub-Investigator: Stephan Diessel         
Sponsors and Collaborators
ikfe-CRO GmbH
IKFE Institute for Clinical Research and Development
Investigators
Principal Investigator: Andreas Pfützner, Professor Ikfe GmbH
  More Information

No publications provided

Responsible Party: ikfe-CRO GmbH
ClinicalTrials.gov Identifier: NCT01500850     History of Changes
Other Study ID Numbers: Lantu_L_05720
Study First Received: December 5, 2011
Last Updated: December 23, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ikfe-CRO GmbH:
Type 2 Diabetes mellitus
NPH insulin
Insulin Glargine
cardiovascular biomarkers
hsCRP, adiponectin
intact proinsulin
cardiovascular risk

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014