Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Key facts

Study ID

NCT01388361

Run by

Novo Nordisk A/S

People needed

413

Starts

2011-09-01

Expected to finish

2012-07-01

Last updated by the study team

2017-03-06

Who can join

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

You may qualify if…

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
• The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
• Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

You may not qualify if…

• Participated in NN1250-3643 and treated with insulin glargine
• Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
• Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
• Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin [For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula] at end of treatment in NN1250-3643.

Where it is running

• Novo Nordisk Investigational Site — La Jolla, California, United States
• Novo Nordisk Investigational Site — Lancaster, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — National City, California, United States
• Novo Nordisk Investigational Site — Northridge, California, United States
• Novo Nordisk Investigational Site — Palm Springs, California, United States
• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Tarzana, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Boynton Beach, Florida, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — New Port Richey, Florida, United States
• Novo Nordisk Investigational Site — Palm Harbor, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Decatur, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Evansville, Indiana, United States
• Novo Nordisk Investigational Site — Paducah, Kentucky, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — North East, Maryland, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Concord, California, United States

Full record on ClinicalTrials.gov

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