Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin, NPH Insulin human Insulin, isophane Insulin glargine Insulin glulisine

U.S. FDA Resources

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

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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 May 22, 2013