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

NCT01035528 | Unknown Phase 4 DMC

• 2 other identifiers: HealthyHeartHOE 901/6035
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Type 2 Diabetes

Keywords

diastolic function, postmeal glucose, insulin glargine

Outcome Measures

Primary Outcomes (1)

• change from baseline to endpoint in myocardial diastolic velocity E'

  24 weeks

Secondary Outcomes (1)

• glucose control

  24 weeks

Study Arms (2)

insulin glargine

ACTIVE COMPARATOR

antidiabetic treatment with Lantus o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl

Drug: insulin glargine

metformin

ACTIVE COMPARATOR

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

Interventions

insulin glargine DRUG

antidiabetic treatment with insulin glargine sc o.d. titrated to the target fasting glucose type 2 diabetes ≤110 mg/dl

Also known as: Lantus

insulin glargine

metformin DRUG

use of oral metformin o.d or b.d titrated up to 2000 mg daily for to the target fasting glucose ≤110 mg/dl

Also known as: Siofor

metformin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• coronary artery disease
• type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose
• treatment by ≤1 OAD

You may not qualify if:

• contraindications for metformin or insulin glargine
• on insulin therapy
• pregnancy and breastfeeding

Sponsors & Collaborators

• Munich Municipal Hospital: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Staedt. Klinikum Muenchen Bogenhausen

Munich, Bavaria, 81925, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Helene von Bibra, MD, PhD

  Diabetes Centre, Staedt. Klinikum Bogenhausen, Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: April 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 18, 2009

Record last verified: 2004-08

Locations

DE (1)