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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by Munich Municipal Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Munich Municipal Hospital
ClinicalTrials.gov Identifier:
NCT01035528
First received: December 17, 2009
Last updated: NA
Last verified: August 2004
History: No changes posted

December 17, 2009
December 17, 2009
April 2005
February 2010   (final data collection date for primary outcome measure)
change from baseline to endpoint in myocardial diastolic velocity E' [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
glucose control [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Type 2 Diabetes
  • Drug: insulin glargine
    antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
    Other Name: Lantus
  • 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 Name: Siofor
  • Active Comparator: insulin glargine
    antidiabetic treatment with Lantus o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
    Intervention: Drug: insulin glargine
  • 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
    Intervention: Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
August 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01035528
HealthyHeart, HOE 901/6035
Yes
Prof. Dr. Helene von Bibra, Munich Municipal Hospital
Munich Municipal Hospital
Aventis Pharmaceuticals
Principal Investigator: Helene von Bibra, MD, PhD Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen
Munich Municipal Hospital
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP