• Conditions: type 2 diabetes; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-021560-15-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-07
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1660

Inclusion Criteria

Subjects with type 2 diabetes • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% • Male or female, age 18 years or above • Subjects on stable dose of 1-2 OADs (metformin [`?¥ 1500 mg or max tolerated dose] or metformin [`?¥ 1500 mg or max tolerated dose] + pioglitazone [`?¥ 30 mg]) for at least 90 days prior to screening • BMI `?¤ 40 kg/m^2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) • Treatment with GLP-1 receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial • Impaired liver function, defined as alanine aminotransferese (ALAT) `?¥ 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Impaired renal function defined as serum-creatinine `?¥ 133 µmol/l (`?¥ 1.5 mg/dl) for males and `?¥ 125 µmol/l (`?¥ 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Screening calcitonin `?¥ 50 ng/L • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures • Severe uncontrolled treated or untreated hypertension (systolic blood pressure `?¥ 180 mm Hg or diastolic blood pressure `?¥ 100 mm Hg) • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) • History of chronic pancreatitis or idiopathic acute pancreatitis

Study & Design

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