Clinical trial to compare the effect of liraglutide and glimepiride, both in combination with metformin in patients with type 2 diabetes

• Conditions: type 2 diabetes; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000311-87-ES
• Lead Sponsor: Fundación Fernández-Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed written consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject).
2.Male or female patients between 18 and 75 years old;
3.Subjects diagnosed with type 2 diabetes for more than 1 year
4.Insulin naïve subjects (Allowed are: Previous short term insulin treatment < 28 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods < 14 days in total)
5.Subjects previously treated with metformin at a minimum dose of 1500 mg/day
6.HbA1c from 7% to 9%
7.Adherence to injection therapy
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Type 1 diabetic patients;
2.Use of a GLP-1 receptor agonist (exenatide, liraglutide or other), pramlintide, thiazolidinediones or any DPP-4 inhibitor within the 3 months prior to screening;
3.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (or their partners). Adequate contraceptive measures are considered the use of hormonal based contraceptives in combination with a barrier contraception,
4.Patients with a clinical history of serious cardiovascular events in the last 3 months (myocardial infarction, unstable angina, cerebral infarction, TIA, peripheral arteriopathic event);
5.Suspected or confirmed acute pancreatitis;
6.Personal history of medullary thyroid carcinoma);
7.Patients with congestive heart failure (NYHA I-IV);
8.Moderate or severe renal failure (creatinine clearance <60 ml/min);
9.Patients with hepatic failure. This is AST or ALT > 3 times the upper limit of normal, history of cirrhosis or hepatitis;
10.Patients with cancer in the last 10 years;
11.Patients with terminal diseases;
12.Patients unlikely to comply with trial procedures;
13.Known psychiatric disease which may interfere with study procedure;
14.Any other pathology which may interfere with the study results at the investigator?s discretion;
15.Known or suspected contraindications to or history of hypersensitivity to the trial product or related products;
16.Previous participation in this trial i.e. randomised;
17.The receipt of any investigational product within 30 days.

Study & Design

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