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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Insulin
Insulin glulisine
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Isophane insulin, beef
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014