A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec/liraglutide; Drug: insulin aspart

• Registration Number: NCT02100475
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study Start: 2014-04
• Study First Posted: 2014-04-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Disposition First Submitted: 2016-11-10
• Disposition First Submitted QC: 2016-11-10
• Disposition First Posted: 2016-11-11
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
• HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

Exclusion Criteria

• Clinically significant diseases of the major organ systems
• Screening calcitonin above or equal to 50 ng/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin degludec/liraglutide + Metformin	insulin degludec/liraglutide	-
Insulin degludec/liraglutide + Insulin Aspart + Metformin	insulin degludec/liraglutide	-
Insulin degludec/liraglutide + Insulin Aspart + Metformin	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Glycosylated Haemoglobin)	Week 0, week 26	Change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0, week 26	Change from baseline in body weight after 26 weeks of treatment.
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes	Week 0 - 26	Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose \< 3.1 mmol/L (56 mg/dL).

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Valencia, Spain