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NCT02100475 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— DUAL™  

Official title:
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 (DUAL™ - Intensification)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02100475
Other study ID # NN9068-4119
Secondary ID 2013-002878-47U1
Status Completed
Phase Phase 3
First received March 27, 2014
Last updated November 10, 2016
Start date April 2014
Est. completion date April 2015

Study information
Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGreece: National Organization of MedicinesHungary: Ministry of Health, Social and Family AffairsMexico: National Institute of Public Health, Health SecretariatRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSouth Africa: Medicines Control CouncilUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Capital Federal
Argentina Novo Nordisk Investigational Site Corrientes
Argentina Novo Nordisk Investigational Site Salta
Argentina Novo Nordisk Investigational Site Zarate
Australia Novo Nordisk Investigational Site East Ringwood Victoria
Australia Novo Nordisk Investigational Site Herston Queensland
Australia Novo Nordisk Investigational Site Ipswich Queensland
Australia Novo Nordisk Investigational Site Robina Queensland
Australia Novo Nordisk Investigational Site Wollongong New South Wales
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Ioannina
Greece Novo Nordisk Investigational Site Larissa
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
Hungary Novo Nordisk Investigational Site Eger
Hungary Novo Nordisk Investigational Site Gyor
Hungary Novo Nordisk Investigational Site Gyula
Hungary Novo Nordisk Investigational Site Miskolc
Mexico Novo Nordisk Investigational Site Cuernavaca Morelos
Mexico Novo Nordisk Investigational Site Mexico City México, D.F.
Mexico Novo Nordisk Investigational Site Monterrey
Mexico Novo Nordisk Investigational Site Pachuca Hidalgo
Russian Federation Novo Nordisk Investigational Site Kazan
Russian Federation Novo Nordisk Investigational Site Kirov
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Novosibirsk
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site St. Petersburg
Russian Federation Novo Nordisk Investigational Site Tomsk
Russian Federation Novo Nordisk Investigational Site Tomsk
Russian Federation Novo Nordisk Investigational Site Volgograd
Slovakia Novo Nordisk Investigational Site Bardejov
Slovakia Novo Nordisk Investigational Site Dolny Kubin
Slovakia Novo Nordisk Investigational Site Kosice
Slovakia Novo Nordisk Investigational Site Levice
Slovakia Novo Nordisk Investigational Site Poprad
Slovakia Novo Nordisk Investigational Site Povazska Bystrica
Slovakia Novo Nordisk Investigational Site Prievidza
Slovakia Novo Nordisk Investigational Site Trnava
Slovakia Novo Nordisk Investigational Site Velky Meder
South Africa Novo Nordisk Investigational Site Alberton
South Africa Novo Nordisk Investigational Site Brits North West
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Midrand Gauteng
Spain Novo Nordisk Investigational Site Almería
Spain Novo Nordisk Investigational Site Granada
Spain Novo Nordisk Investigational Site Palma de Mallorca
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Valencia
United States Novo Nordisk Investigational Site Altoona Pennsylvania
United States Novo Nordisk Investigational Site Fort Lauderdale Florida
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Gurnee Illinois
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Renton Washington
United States Novo Nordisk Investigational Site Slidell Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Greece,  Hungary,  Mexico,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c (glycosylated haemoglobin) Week 0, week 26 No
Secondary Change from baseline in body weight Week 0, week 26 No
Secondary Number of treatment-emergent confirmed hypoglycaemic episodes Week 0 - 26 No
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