Clinical trial NCT02100475: 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Week 0, week 26
measure: Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 - 26
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Gurnee
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Slidell
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Altoona
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Corrientes
country: Argentina
facility: Novo Nordisk Investigational Site
city: Salta
country: Argentina
facility: Novo Nordisk Investigational Site
city: Zarate
country: Argentina
facility: Novo Nordisk Investigational Site
city: Wollongong
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Ipswich
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Robina
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: East Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Ioannina
country: Greece
facility: Novo Nordisk Investigational Site
city: Larissa
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Eger
country: Hungary
facility: Novo Nordisk Investigational Site
city: Gyor
country: Hungary
facility: Novo Nordisk Investigational Site
city: Gyula
country: Hungary
facility: Novo Nordisk Investigational Site
city: Miskolc
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pachuca
country: Mexico
facility: Novo Nordisk Investigational Site
state: Hidalgo
city: Cuernavaca
country: Mexico
facility: Novo Nordisk Investigational Site
state: Morelos
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kirov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Volgograd
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Bardejov
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Dolny Kubin
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Levice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Poprad
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Prievidza
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Trnava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Velky Meder
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Midrand
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Alberton
country: South Africa
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: