A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02420262
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- Male or female, age at least 18 years at the time of signing informed consent
- Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
- HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
- Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
- Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
- Body mass index (BMI) below or equal to 40 kg/m^2
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
- Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
- Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
- Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Screening calcitonin at least 50 ng/L
- History of pancreatitis (acute or chronic)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDegLira insulin degludec/liraglutide - IGlar plus IAsp insulin glargine - IGlar plus IAsp insulin aspart -
- Primary Outcome Measures
Name Time Method Change in HbA1c (Glycosylated Haemoglobin) Week 0, Week 26 Change in HbA1c values after 26 weeks of treatment.
- Secondary Outcome Measures
Name Time Method Responder for HbA1c Below or Equal to 6.5 % After 26 weeks of treatment Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes. Weeks 0-26 Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
Change in Body Weight Week 0, Week 26 Change in body weight after 26 weeks of treatment.
Responder for HbA1c Below 7.0% After 26 weeks of treatment Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇷Istanbul, Turkey