Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin degludec/liraglutide: Injected subcutaneously (under the skin) once daily for 26 Weeks.
The dosewill be individually adjusted. All subjects will continue their pre-trial SU trea
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: Age limit above 18 years Subjects with type 2 diabetes mellitus HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive) Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1) Body Mass Index (BMI) below or equal to 40 kg m2
Exclusion criteria
Exclusion criteria: Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 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 above or equal to 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 Investigatorâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycosylated haemoglobin (HbA1c)Timepoint: Week 0, Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in body weightTimepoint: Week 0, week 26;Change from baseline in fasting plasma glucoseTimepoint: Week 0,Week 26;Number of adverse events (AEs)Timepoint: After 26 weeks of treatment;Number of severe or minor hypoglycaemic episodesTimepoint: After 26 weeks of treatment;Responders achieving pre-defined target: HbA1c below 7.0%Timepoint: Week 26;Responders achieving pre-defined target: HbA1c below or equal to 6.5%Timepoint: Week 26 | — |
Countries
Bulgaria, Canada, Germany, India, Israel, The former Yugoslav Republic of Macedonia, Turkey, United States of America
Contacts
Public ContactMr Avik Kumar Gosh
Novo Nordisk India Private Ltd
Outcome results
None listed