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

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02420262

Run by

Novo Nordisk A/S

People needed

506

Starts

2015-07-26

Expected to finish

2016-10-05

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Bermuda Dunes, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Lancaster, California, United States
• Novo Nordisk Investigational Site — Lincoln, California, United States
• Novo Nordisk Investigational Site — Lomita, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Montclair, California, United States
• Novo Nordisk Investigational Site — Northridge, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Waterbury, Connecticut, United States
• Novo Nordisk Investigational Site — Palm Harbor, Florida, United States
• Novo Nordisk Investigational Site — Plantation, Florida, United States
• Novo Nordisk Investigational Site — Blackfoot, Idaho, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Skokie, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — Natchitoches, Louisiana, United States
• Novo Nordisk Investigational Site — Shreveport, Louisiana, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Waltham, Massachusetts, United States
• Novo Nordisk Investigational Site — Billings, Montana, United States
• Novo Nordisk Investigational Site — Tuscumbia, Alabama, United States

Full record on ClinicalTrials.gov

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