A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

Key facts

Study ID

NCT02501161

Run by

Novo Nordisk A/S

People needed

1012

Starts

2016-01-31

Expected to finish

2018-10-03

Last updated by the study team

2019-11-27

Who can join

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

You may qualify if…

• Male or female, age greater than or equal to 18 years at the time of signing informed consent
• Subjects diagnosed with type 2 diabetes mellitus
• HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis
• Body mass index greater than or equal to 20 kg/m\^2
• Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
• Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record)

You may not qualify if…

• Screening calcitonin greater than or equal to 50 ng/L
• Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening
• Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal
• Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
• History of pancreatitis (acute or chronic)
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
• Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Where it is running

• Novo Nordisk Investigational Site — Tuscumbia, Alabama, United States
• Novo Nordisk Investigational Site — Glendale, Arizona, United States
• Novo Nordisk Investigational Site — Glendale, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, 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 — Monterey, California, United States
• Novo Nordisk Investigational Site — Sacramento, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Boynton Beach, Florida, United States
• Novo Nordisk Investigational Site — Lake Worth, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Blackfoot, Idaho, United States
• Novo Nordisk Investigational Site — Avon, Indiana, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — Hyattsville, Maryland, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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