A trial to investigate the efficacy and safety of insulin degludec/liraglutide in subjects inadequately controlled with sulphonylurea alone or in combination with metformin.
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2012/10/003039
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in glycosylated haemoglobin (HbA1c)Timepoint: Week 0, Week 26 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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