A trial comparing the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-004413-14-HU
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 554
• Type 2 diabetes mellitus
• =18 years of age
• HbA1c 7.0-10.0% [53-86 mmol/mol] (both inclusive) by central laboratory analysis
• Current treatment with insulin glargine for at least 90 days prior to screening
• Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of ± 10% within the 56 days prior to screening are acceptable.
• Stable daily dose of metformin (= 1500 mg or max tolerated dose) for at least 90 days prior to screening
• 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 444
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
• Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening)
• Current use of any drug (except metformin and insulin glargine) or anticipated change in concomitant medication, which in the investigator’s opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids)
• Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator)
• Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
• Impaired liver function, defined as ALAT =2.5 times upper normal range (UNR)
• Impaired renal function defined as serum-creatinine =133µmol/L (=1.5 mg/dL) for males and =125 µmol/L (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin
• Screening calcitonin =50 ng/L
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• 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 Main Objective: To confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes mellitus (T2DM) on previous treatment with insulin glargine.<br><br>This is done by comparing the difference in change in glycosylated haemoglobin (HbA1c) from baseline after 26 weeks of treatment to a non-inferiority limit of 0.30% for insulin degludec/liraglutide vs insulin glargine.;Secondary Objective: • To confirm superiority of insulin degludec/liraglutide versus insulin glargine after 26 weeks of treatment on one or more of the following:<br> o Change from baseline in HbA1c<br> o Confirmed hypoglycaemia<br> o Change from baseline in body weight<br>• To compare safety of insulin degludec/liraglutide to insulin glargine after 26 weeks of treatment;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from baseline in body weight <br>2. Number of treatment emergent confirmed hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment<br>2. During 26 weeks of treatment