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

Part of paid clinical trials in Fresno, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT02100475
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • insulin degludec/liraglutide — DRUG
    Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted.
  • insulin aspart — DRUG
    Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Study Details

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).

Key Dates

First listed
Apr 1, 2014
Start date
Apr 30, 2014
Status verified
Nov 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin degludec/liraglutide + Metformin
  • Active Comparator: Insulin degludec/liraglutide + Insulin Aspart + Metformin

Primary Outcome Measure

Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 26 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteFresnoCalifornia93720-
Novo Nordisk Investigational SiteFort LauderdaleFlorida33316-2521-
Novo Nordisk Investigational SiteGurneeIllinois60031-
Novo Nordisk Investigational SiteLexingtonKentucky40503-
Novo Nordisk Investigational SiteSlidellLouisiana70461-4231-
Novo Nordisk Investigational SiteAltoonaPennsylvania16602-
Novo Nordisk Investigational SiteRentonWashington98057-

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EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Fresno, CANovo Nordisk Investigational Site· Fort Lauderdale, FLNovo Nordisk Investigational Site· Gurnee, ILNovo Nordisk Investigational Site· Lexington, KYNovo Nordisk Investigational Site· Slidell, LANovo Nordisk Investigational Site· Altoona, PA

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