The effect of liraglutide on the treatment of coronary artery disease and type 2 diabetes

Phase 1

• Conditions: Patients suffering of both Type 2 diabetes mellitus and coronary artery disease; MedDRA version: 14.1Level: LLTClassification code 10011079Term: Coronary artery disease NOSSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005405-78-DK
• Lead Sponsor: Steen Bendix Haugaard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-04
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Stable CAD documented by either;
a)previous MI (a minimum of 6 weeks after acute MI)
b)previous coronary revascularization
c)CAD confirmed by an abnormal coronary arteriograph (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries.
Body mass index (BMI) >/= 25,0 kg/m2
Age from 18 to 85 years of age
Type 2 diabetes diagnosed either as:
a)HbA1c >/= 6.5% but b)HbA1c <6.5 % and fasting plasma glucose >/= 7.0 mmol/l (confirmed)
c)HbA1c <6.5 % and a 2 h plasma glucose value during OGTT >/= 11.1 mmol/l
The data for glucose metabolism are accepted provided that they have been obtained within 20 weeks before screening of the patient. The glucose metabolic categories are defined by ADA and WHO criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Type 1 diabetes mellitus defined as C-peptide < 450 pM
Previously diagnosed diabetes mellitus before screening by OGTT except from previous gestational diabetes
Previous use of antidiabetic medication except from use during previous gestational diabetes. It is accepted that the patient has been treated with oral anti diabetic drugs (OAD) after diagnosis of T2D as long as the patient pause OAD at least 4 weeks before baseline measurements in this trial
Significant heart disease (NYHA > 2; Ejection Fraction < 40%, unstable angina pectoris, atrial fibrillation)
Liver disease (transaminases > x2 greater than upper normal level)
Renal diseases (eGFR < 50)
Any chronic medical condition to unduly increase risk for the potential enrollee as judge by study investigators
Anemia (<85% of lower normal limit), leucopenia (<85% of lower normal limit), or thrombocytopenia (< 85% of lower normal limit)
Pregnancy or failure to comply with contraceptional planning within two years, or breastfeeding
Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
Use of immunosuppressive therapy in the preceding 12 months
Chronic pancreatitis / previous acute pancreatitis
Known or suspected hypersensitivity to trial product(s) or related products
Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics (Exenatide), which in the Investigator’s opinion could interfere with glucose metabolism
Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the Investigator’s opinion could interfere with the results of the trail
Inflammatory bowel disease
Previous bowel resection
Clinical signs of diabetic gastroparesis
The receipt of any investigational product 90 days prior to this trial
Screening calcitonin = 50 ng/l
Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Refusal to sign informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified