Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.

Key facts

Study ID

NCT01365507

Run by

Novo Nordisk A/S

People needed

276

Starts

2011-06-01

Expected to finish

2012-04-01

Last updated by the study team

2017-03-17

Who can join

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

You may qualify if…

• Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
• Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
• Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
• HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
• BMI (Body Mass Index) below or equal to 45 kg/m\^2
• Ability and willingness to adhere to the protocol including self measurement of plasma glucose

You may not qualify if…

• Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
• Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
• Known or suspected hypersensitivity to trial products or related products
• The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
• Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits

Where it is running

• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Montclair, California, United States
• Novo Nordisk Investigational Site — Palm Springs, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Pembroke Pines, Florida, United States
• Novo Nordisk Investigational Site — Crestview Hills, Kentucky, United States
• Novo Nordisk Investigational Site — Madisonville, Kentucky, United States
• Novo Nordisk Investigational Site — Paducah, Kentucky, United States
• Novo Nordisk Investigational Site — Hyattsville, Maryland, United States
• Novo Nordisk Investigational Site — North East, Maryland, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — Troy, Michigan, United States
• Novo Nordisk Investigational Site — Eagan, Minnesota, United States
• Novo Nordisk Investigational Site — Smithtown, New York, United States
• Novo Nordisk Investigational Site — Asheboro, North Carolina, 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 — Lubbock, Texas, United States
• Novo Nordisk Investigational Site — Sugar Land, Texas, United States
• Novo Nordisk Investigational Site — Newport News, Virginia, United States
• Novo Nordisk Investigational Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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