NN1250-3944 Degludec Add On to Liraglutide

• Research type

  Research Study

• Full title

  The effect of insulin degludec in combination with liraglutide and metformin in subjects with type 2 diabetes qualifying for treatment intensification

• IRAS ID

  109302

• Contact name

  Srikanth Bellary

• Eudract number

  2011-004665-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The rationale for this trial is to investigate the combination of IDeg and liraglutide. IDeg is an insulin analogue mimicking the body??s basal insulin with an ultra-long action profile and a low risk of hypoglycaemia (low blood glucose levels). Liraglutide is a GLP-1 analogue, which increases postprandial (after eating) insulin stimulation, glucagon suppression and slows down digestion. The proposed study is a 26-week, randomised (1:1), parallel, double-blind, multi-national, controlled trial comparing efficacy and safety of IDeg to placebo; both in combination with liraglutide and metformin in subjects with type 2 diabetes mellitus qualifying for treatment intensification. The total trial duration for the individual subjects will be up to 44 weeks. The trial includes a screening visit (Visit 1), a 15-week run-in period, followed by frequent visits during the 26-week randomised treatment period and a follow-up visit at least 7 days after the actual date of the last treatment visit. After completion of the run-in period, subjects will be treated with IDeg or placebo once daily, both in combination with liraglutide 1.8 mg daily metformin = 1500 mg daily or maximum tolerated dose. Liraglutide treatment will be initiated at 0.6 mg daily for one week and increased to 1.2 mg daily and further to 1.8 mg daily after the second week in the run-in period. During the run-in and the randomised treatment period, the daily metformin and liraglutide dose (after dose increase to 1.8 mg) should remain unchanged. IDeg and placebo will be injected once daily and doses will be adjusted based on the average of the pre-breakfast SMPG (self-monitored plasma glucose) levels measured on the day of the contact and the two days immediately prior to the contact. It is planned that 1345 patients will be screened in order to enter 941 into the run-in phase. Countries planned to participate are Canada, France, Germany, United Kingdom, Italy, Serbia, United States, Ukraine, Israel, South Africa, and United Arab Emirates.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0380

• Date of REC Opinion

  25 Jul 2012

• REC opinion

  Further Information Favourable Opinion