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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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Type 2 Diabetes
Drug: insulin glargine
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Munich Municipal Hospital:

Primary Outcome Measures:
  • change from baseline to endpoint in myocardial diastolic velocity E' [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose control [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2005
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Siofor

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035528

Locations
Germany
Staedt. Klinikum Muenchen Bogenhausen
Munich, Bavaria, Germany, 81925
Sponsors and Collaborators
Munich Municipal Hospital
Aventis Pharmaceuticals
Investigators
Principal Investigator: Helene von Bibra, MD, PhD Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen
  More Information

No publications provided

Responsible Party: Prof. Dr. Helene von Bibra, Munich Municipal Hospital
ClinicalTrials.gov Identifier: NCT01035528     History of Changes
Other Study ID Numbers: HealthyHeart, HOE 901/6035
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Munich Municipal Hospital:
diastolic function, postmeal glucose, insulin glargine

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014