Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
Recruitment status was Active, not recruiting
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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 |
- change from baseline to endpoint in myocardial diastolic velocity E' [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 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 |
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| Germany | |
| Staedt. Klinikum Muenchen Bogenhausen | |
| Munich, Bavaria, Germany, 81925 | |
| 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 Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine Insulin Hypoglycemic Agents Metformin Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013