Ignite Creation Date:
2024-05-05 @ 10:08 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01035528
Status:
UNKNOWN
Last Update Posted:
2009-12-18
First Post:
2009-12-17
Brief Title:
Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease CAD
Sponsor:
Munich Municipal Hospital
Organization:
Munich Municipal Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2004-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 od 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
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 od 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 mgdl 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 studyOutpatients 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
In one treatment arm therapy is based on insulin glargine sc od 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 mgdl 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 studyOutpatients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HOE 9016035 | OTHER | Aventis-Sanofi | None |