Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DUAL™

NCTNCT02100475Other idNN9068-4119Other id2013-002878-47Other idU1111-1145-0183

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 31 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 10 countries
United States, Argentina, Australia, Greece, Hungary, Mexico, Russia, Slovakia, South Africa, Spain
Start: Apr 2014
Primary completion: Apr 2015
Completion: Apr 2015
First posted: 1 Apr 2014 (estimated)
Last update posted: 20 Jan 2017 (estimated)
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016

Ph 3
DUAL™
NCT02100475
Apr 2014 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

insulin degludec/liraglutideDrug
insulin aspartDrug

Arms2

Experimental
Insulin degludec/liraglutide + Metformin
Active comparator
Insulin degludec/liraglutide + Insulin Aspart + Metformin

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, week 26
Registry description
Change from baseline in HbA1c after 26 weeks of treatment.

Secondary outcomes(2)

Change From Baseline in Body Weight
Time frame · Week 0, week 26
Registry description
Change from baseline in body weight after 26 weeks of treatment.
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
Time frame · Week 0 - 26
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 26

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Group	Value (Percentage of glycosylated haemoglobin)	Spread
IDegLira	-0.43	0.94
IDegLira + IAsp	-0.14	1.09

Secondary and other outcome results(2)

Secondary outcomeMean· Week 0, week 26

Change From Baseline in Body Weight

Group	Value (Kilograms)	Spread
IDegLira	0.9	2.1
IDegLira + IAsp	1.5	3.2

Secondary outcomeNumber· Week 0 - 26

Number of Treatment-emergent Confirmed Hypoglycaemic Episodes

Group	Value (Number of episodes)
IDegLira	34
IDegLira + IAsp	4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
IDegLiraInsulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).	–	1 / 16	11 / 16
IDegLira + IAspIDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).	–	2 / 15	3 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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