The efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on GLP-1 receptor agonist and metformin therapy

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 15.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000209-63-SK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

- Subjects with type 2 diabetes mellitus
- Male or female = 18 years of age
- HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg OD Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (= 1500 mg or documented maximum tolerated dose) = 90 days prior to screening visit (Visit 1)
- BMI (body mass index) = 40 kg/m2
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 321
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

- Any use of oral anti-diabetic drugs (OADs) (except for metformin) = 90 days prior to screening visit (Visit 1)
- Use of any drug (except metformin and GLP-1 receptor agonist) which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- Screening calcitonin = 50 ng/l
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion
- Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
- History of chronic pancreatitis or idiopathic acute pancreatitis

Study & Design

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