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: WeighthsCRP 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
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