Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
Primary Purpose
Coronary Artery Disease, Type 2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
insulin glargine
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring diastolic function, postmeal glucose, insulin glargine
Eligibility 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
Sites / Locations
- Staedt. Klinikum Muenchen Bogenhausen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
insulin glargine
metformin
Arm Description
antidiabetic treatment with Lantus o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
Outcomes
Primary Outcome Measures
change from baseline to endpoint in myocardial diastolic velocity E'
Secondary Outcome Measures
glucose control
Full Information
NCT ID
NCT01035528
First Posted
December 17, 2009
Last Updated
December 17, 2009
Sponsor
Munich Municipal Hospital
Collaborators
Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01035528
Brief Title
Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Munich Municipal Hospital
Collaborators
Aventis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Type 2 Diabetes
Keywords
diastolic function, postmeal glucose, insulin glargine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
insulin glargine
Arm Type
Active Comparator
Arm Description
antidiabetic treatment with Lantus o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
Arm Title
metformin
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Siofor
Intervention Description
use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl
Primary Outcome Measure Information:
Title
change from baseline to endpoint in myocardial diastolic velocity E'
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
glucose control
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene von Bibra, MD, PhD
Organizational Affiliation
Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staedt. Klinikum Muenchen Bogenhausen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany
12. IPD Sharing Statement
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Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)
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