A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Key facts

Study ID

NCT01713530

Run by

Novo Nordisk A/S

People needed

274

Starts

2013-02-21

Expected to finish

2014-01-09

Last updated by the study team

2018-04-02

Who can join

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

You may qualify if…

• Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
• Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
• HbA1c 7.0% - 10.0%
• Body mass index (BMI) less than or equal to 40.0 kg/m\^2

You may not qualify if…

• Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
• Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
• Chronic disorder or disease which might jeopardise safety or compliance
• Malignant neoplasms
• Recurrent severe hypoglycaemia

Where it is running

• Novo Nordisk Investigational Site — Mission Hills, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Buckley, Michigan, United States
• Novo Nordisk Investigational Site — Hillsborough, New Jersey, United States
• Novo Nordisk Investigational Site — Lawrenceville, New Jersey, United States
• Novo Nordisk Investigational Site — Toms River, New Jersey, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — Whiteville, North Carolina, United States
• Novo Nordisk Investigational Site — Kettering, Ohio, United States
• Novo Nordisk Investigational Site — Wadsworth, Ohio, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Kingsport, Tennessee, United States
• Novo Nordisk Investigational Site — Austin, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Round Rock, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States
• Novo Nordisk Investigational Site — Tacoma, Washington, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States

Full record on ClinicalTrials.gov

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