The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy

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)
- Subjects on stable daily dose of sulphonylurea (= half of the max approved dose according to local label) with or without metformin (= 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
- Body Mass Index (BMI) = 40 kg/m^2
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) (other than SU in monotherapy or in combination with metformin) = 90 days prior to screening visit (Visit 1)
- Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
- 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 product
- History of chronic pancreatitis or idiopathic acute pancreatitis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials