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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin aspart

Drug: insulin glargine

Drug: insulin degludec/liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02420262

U1111-1160-6923 (Other Identifier)

2014-003621-18 (EudraCT Number)

REec-2015-1682 (Registry Identifier)

NN9068-4185

Details and patient eligibility

About

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.

Enrollment

506 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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