Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)

December 17, 2009 updated by: Munich Municipal Hospital

Healthy Heart Study: Can Insulin Glargine Improve Myocardial Function in Patients With Type 2 Diabetes and Coronary Artery Disease? A Prospective, Randomized, Controlled Clinical Study With Blinded Analysis of Ultrasound Data

The field of secondary prevention remains an extremely important goal for diagnostic and therapeutic approaches keeping in mind that 40% of all patients with acute myocardial infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known and treated and for which there are no guidelines for treatment. In this context, accumulating evidence shows beneficial effects for treating diabetes mellitus early in the course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be associated with undesired risks. Accordingly, the present randomized and controlled pilot study is designed as hypothesis creating study to create first data about potential medication in early type 2 diabetes including impaired glucose tolerance of patients with known coronary artery disease as means of secondary prevention by comparing oral antidiabetic therapy with metformin with insulin glargine o.d. and by studying the respective effects on cardiovascular function and metabolism both in the fasting state and after a standardized meal. As diastolic myocardial function has emerged as important prognosticator, the hypothesis was tested that treatment with insulin glargine improves myocardial function in patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired glucose tolerance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single centre, short term (24 weeks), therapy controlled and randomized prospective study with blinded analysis of the ultrasound data in 28 patients with known coronary artery disease, normal systolic cardiac function and with newly diagnosed type 2 diabetes including impaired glucose tolerance who are treated by ≤1 oral antidiabetic medication. After recruitment and informed consent, patients are randomized to two treatment arms which takes into account age and presence or absence of therapy with statins.

In one treatment arm, therapy is based on insulin glargine sc o.d., while in the other treatment arm, therapy is based on oral metformin, up to 2000 mg daily. Both treatment arms will be titrated to the target of fasting glucose ≤110 mg/dl during the first 12 weeks. The patients in the insulin treatment arm will be instructed in the skills of self-medication by the departmental diabetic teaching programme prior to starting study medication and are encouraged to keep records of any episode of hypoglycemia throughout the study.Outpatients visits for metabolic control and ultrasound assessment are at weeks 4, 12 and 24 after baseline and are associated with life style instructions for all patients.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81925
        • Staedt. Klinikum Muenchen Bogenhausen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • coronary artery disease
  • type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose
  • treatment by ≤1 OAD

Exclusion Criteria:

  • contraindications for metformin or insulin glargine
  • on insulin therapy
  • pregnancy and breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: insulin glargine
antidiabetic treatment with Lantus o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
Drug: insulin glargine
antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
Other Names:
  • Lantus
Active Comparator: metformin
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
Drug: metformin
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
Other Names:
  • Siofor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline to endpoint in myocardial diastolic velocity E'
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
glucose control
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Munich Municipal Hospital

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Helene von Bibra, MD, PhD, Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2009

Last Update Submitted That Met QC Criteria

December 17, 2009

Last Verified

August 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HealthyHeart
  • HOE 901/6035 (Other Identifier: Aventis-Sanofi)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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