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Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

NCT01500850 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-12-29

No results posted yet for this study

Summary

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

Conditions

  • Insulin-requiring Type 2 Diabetes Mellitus

Interventions

DRUG

nph insulin

Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.

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

DRUG

Insulin Glargine

Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.

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

Sponsors & Collaborators

  • IKFE Institute for Clinical Research and Development

    collaborator OTHER

  • ikfe-CRO GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Pfützner, Professor · Ikfe GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500850 on ClinicalTrials.gov