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Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

Information source: ikfe-CRO GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Insulin-requiring Type 2 Diabetes Mellitus

Intervention: nph insulin (Drug); human insulin (Drug); Insulin Glargine (Drug); Insulin glulisine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: ikfe-CRO GmbH

Official(s) and/or principal investigator(s):
Andreas Pfützner, Professor, Principal Investigator, Affiliation: Ikfe GmbH

Overall contact:
Andreas Pfützner, Professor, Phone: 00496131-57636-0, Ext: 20, Email: andreasp@ikfe.de

Summary

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

Clinical Details

Official title: Establishing Cardiovascular Biomarkers to Define Preferred Lantus Use.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Fasting Intact Proinsulin

Secondary outcome:

Weight

hsCRP

Adiponectin

MMP-9

OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks

HOMA-IR score

HbA1c

Weight

hsCRP

Adiponectin

Fasting intact Proinsulin

Glucose

HbA1c

Responder rate

Hypoglycemic events.

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: To evaluate changes in the parameters

- insulin,

- glucose,

- intact proinsulin (after a glucose challenge),

- hsCRP,

- adiponectin,

- MMP-9,

- HbA1c,

- weight

after 24 weeks of treatment. To investigate the changes of

- glucose,

- intact proinsulin,

- hsCRP,

- adiponectin,

- HbA1c

- weight

between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks). To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).

- Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2

(Baseline) and Visit 8 (after 24 week treatment)

- Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of

treatment and compared versus baseline assessment.

- Weight

- hsCRP

- Adiponectin

- MMP-9

- OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120

minutes after 24 weeks

- HOMA-IR score

- HbA1c

Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:

- Weight

- hsCRP

- Adiponectin

- Fasting intact Proinsulin

- Glucose

- HbA1c

- Safety Variables:

- Adverse Events

- Hypoglycaemic events

Medication/Dosage: Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)

- Study Duration: Duration of study participation for one patient is approximately 26 weeks.

Overall total duration of the study is approximately 10 months. Design: This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Andreas Pfützner, Professor, Phone: 00496131-57636-0, Ext: 20, Email: andreasp@ikfe.de

ikfe GmbH, Mainz, Rheinland-Pfalz 55116, Germany; Recruiting
Thomas Forst, MD, Phone: +49(0) 6131-576 36 -40, Ext: 16, Email: thomasf@ikfe.de
Daniela Sachsenheimer, MD, Phone: +49(0) 6131-576 36 40, Ext: 46, Email: danielas@ikfe.de
Daniela Sachsenheimer, MD, Sub-Investigator
Stephanie Helleberg, MD, Sub-Investigator
Stephan Diessel, Sub-Investigator
Additional Information

Starting date: October 2011
Last updated: December 23, 2011

Page last updated: August 23, 2015

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