Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedDecember 29, 2011
December 1, 2011
1 year
December 5, 2011
December 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting Intact Proinsulin
The difference of fasting intact proinsulin after 24 weeks of treatment compared to baseline.
Change from baseline at 24 weeks
Secondary Outcomes (15)
Weight
Baseline and after 24 weeks of treatment.
hsCRP
Baseline and after 24 weeks of treatment.
Adiponectin
Baseline and after 24 weeks of treatment.
MMP-9
Baseline and after 24 weeks of treatment.
OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
Baseline and after 24 weeks of treatment.
- +10 more secondary outcomes
Study Arms (4)
NPH insulin + insulin glulisine
ACTIVE COMPARATORPatients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
NPH insulin + human insulin
ACTIVE COMPARATORPatients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.
Insulin glargine + insulin glulisine
EXPERIMENTALPatients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
Insulin Glargine + Human insulin
EXPERIMENTALPatients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.
Interventions
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ikfe GmbH
Mainz, Rhineland-Palatinate, 55116, Germany
Related Publications (1)
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PMID: 33166419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Pfützner, Professor
Ikfe GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 29, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 29, 2011
Record last verified: 2011-12