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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002878-47-ES

Enrollment

Registered

2014-01-16

Start date

2014-01-27

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: Insulin degludec liraglutide PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN DEGLUDEC CAS Number: 844439-96-9 Concentration unit: U/ml unit(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin. 2. HbA1c ? 7% at Visit 27 of NN9068-3952 trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: 1. Clinically significant diseases of the major organ systems. 2. Screening calcitonin ? 50ng/L.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the efficacy of dose adjustment of insulin degludec/liraglutide to a maximum dose of 80 dose steps as compared to adding insulin aspart to insulin degludec/liraglutide with a maximum dose of 50 dose steps, both arms in combination with metformin, in controlling glycaemia.;Secondary Objective: To explore efficacy in terms of other measures of glycaemic control, safety and patient reported outcomes (PRO) of dosing insulin degludec/liraglutide to a maximum dose of 80 dose steps, as compared to adding insulin aspart to insulin degludec/liraglutide, both arms in combination with metformin, in controlling glycaemia.;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment	—

Measure

Time frame

Main Objective: To explore the efficacy of dose adjustment of insulin degludec/liraglutide to a maximum dose of 80 dose steps as compared to adding insulin aspart to insulin degludec/liraglutide with a maximum dose of 50 dose steps, both arms in combination with metformin, in controlling glycaemia.;Secondary Objective: To explore efficacy in terms of other measures of glycaemic control, safety and patient reported outcomes (PRO) of dosing insulin degludec/liraglutide to a maximum dose of 80 dose steps, as compared to adding insulin aspart to insulin degludec/liraglutide, both arms in combination with metformin, in controlling glycaemia.;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in body weight 2. Number of treatment-emergent confirmed hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment 2. During 26 weeks of treatment	—

Countries

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

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com+34913 349 800

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026