The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Key facts

Study ID

NCT01676116

Run by

Novo Nordisk A/S

People needed

438

Starts

2012-08-29

Expected to finish

2014-03-11

Last updated by the study team

2019-01-03

Who can join

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

You may qualify if…

• Subjects with type 2 diabetes mellitus
• Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
• Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
• BMI (body mass index) equal to or below 40 kg/m\^2

You may not qualify if…

• Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
• Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
• Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
• Screening calcitonin equal to or above 50 ng/l
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
• Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
• Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
• History of chronic pancreatitis or idiopathic acute pancreatitis

Where it is running

• Novo Nordisk Investigational Site — Goodyear, Arizona, United States
• Novo Nordisk Investigational Site — Mesa, Arizona, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Encino, California, United States
• Novo Nordisk Investigational Site — Fair Oaks, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States
• Novo Nordisk Investigational Site — Lancaster, California, United States
• Novo Nordisk Investigational Site — Lomita, California, United States
• Novo Nordisk Investigational Site — Long Beach, 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 — San Ramon, California, United States
• Novo Nordisk Investigational Site — Tarzana, California, United States
• Novo Nordisk Investigational Site — Van Nuys, California, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Bradenton, Florida, United States
• Novo Nordisk Investigational Site — Fort Myers, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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