Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
NCT ID: NCT01500850
Last Updated: 2011-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2011-10-31
2012-10-31
Brief Summary
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Detailed Description
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* 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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NPH insulin + insulin glulisine
Patients will be randomized to be treated with NPH insulin + Insulin Glulisine for 24 weeks.
nph insulin
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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
NPH insulin + human insulin
Patients will be randomized to be treated with NPH insulin + human insulin for 24 weeks.
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
Insulin glargine + insulin glulisine
Patients will be randomized to be treated with insulin glargine + insulin glulisine for 24 weeks.
Insulin Glargine
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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
Insulin Glargine + Human insulin
Patients will be randomized to be treated with insulin glargine + human insulin for 24 weeks.
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
Insulin Glargine
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
Interventions
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nph insulin
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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
Insulin Glargine
Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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IKFE Institute for Clinical Research and Development
OTHER
ikfe-CRO GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Pfützner, Professor
Role: PRINCIPAL_INVESTIGATOR
Ikfe GmbH
Locations
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ikfe GmbH
Mainz, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Thomas Forst, MD
Role: primary
Daniela Sachsenheimer, MD
Role: backup
References
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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.
Other Identifiers
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Lantu_L_05720
Identifier Type: -
Identifier Source: org_study_id