A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2016-10-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Xultophy

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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