A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Europe, North America and the United States of America. The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Key facts

Study ID

NCT02298192

Run by

Novo Nordisk A/S

People needed

420

Starts

2014-11-21

Expected to finish

2015-12-23

Last updated by the study team

2017-05-23

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus
• Male or female equal to or above 18 years of age
• HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
• Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
• Body Mass Index (BMI) below or equal to 40 kg/m\^2

You may not qualify if…

• Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
• Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
• Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
• Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
• Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
• Screening calcitonin above or equal to 50 ng/L
• Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• History of pancreatitis (acute or chronic)

Where it is running

• Novo Nordisk Investigational Site — Coquitlam, British Columbia, Canada
• Novo Nordisk Investigational Site — Surrey, British Columbia, Canada
• Novo Nordisk Investigational Site — Moncton, New Brunswick, Canada
• Novo Nordisk Investigational Site — Halifax, Nova Scotia, Canada
• Novo Nordisk Investigational Site — Liverpool, Nova Scotia, Canada
• Novo Nordisk Investigational Site — London, Ontario, Canada
• Novo Nordisk Investigational Site — Waterloo, Ontario, Canada
• Novo Nordisk Investigational Site — Olomouc, Lazce, Czechia
• Novo Nordisk Investigational Site — Pilsen, Czechia
• Novo Nordisk Investigational Site — Pilsen, Czechia
• Novo Nordisk Investigational Site — Prague, Czechia
• Novo Nordisk Investigational Site — Trutnov, Czechia
• Novo Nordisk Investigational Site — Budapest, Hungary
• Novo Nordisk Investigational Site — Budapest, Hungary
• Novo Nordisk Investigational Site — Debrecen, Hungary
• Novo Nordisk Investigational Site — Szombathely, Hungary
• Novo Nordisk Investigational Site — Zalaegerszeg, Hungary
• Novo Nordisk Investigational Site — Barnaul, Russia
• Novo Nordisk Investigational Site — Barnaul, Russia
• Novo Nordisk Investigational Site — Cheboksary, Russia
• Novo Nordisk Investigational Site — Saint Petersburg, Russia
• Novo Nordisk Investigational Site — Saint Petersburg, Russia
• Novo Nordisk Investigational Site — Samara, Russia
• Novo Nordisk Investigational Site — Belgrade, Serbia
• Novo Nordisk Investigational Site — Burnaby, British Columbia, Canada

Full record on ClinicalTrials.gov

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