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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

Short name DUAL™ II

NCTNCT01392573 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3912Other id2011-002336-72Other idU1111-1121-4897
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
413 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
7 countries

United States, Bulgaria, Denmark, Hungary, India, Slovenia, Switzerland

Start
28 Nov 2011
Primary completion
1 Oct 2012
Completion
4 Oct 2012
First posted
12 Jul 2011 (estimated)
Last update posted
3 Jan 2019
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
201120122013
  1. Ph 3

    DUAL™ II

    NCT01392573

    28 Nov 2011 to 4 Oct 2012

Registry summary

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

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin degludecDrug

Arms2

  • Experimental

    IDegLira + metformin

    IDegLira was injected subcutaneously once daily for 26 weeks.

  • Experimental

    IDeg + metformin

    IDeg was injected subcutaneously once daily for 26 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Time frame · Week 0, week 26

    Registry description

    Observed mean change from baseline in HbA1c after 26 Weeks of treatment.

Secondary outcomes(1)

  1. Change in Body Weight

    Time frame · Week 0, week 26

    Registry description

    Observed mean change from baseline in body weight after 26 Weeks of treatment.

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)

GroupValue (percentage of glycosylated haemoglobin)Spread
IDegLira-1.901.09
IDeg-0.891.18
Secondary and other outcome results(1)
Secondary outcomeMean· Week 0, week 26

Change in Body Weight

GroupValue (kg)Spread
IDegLira-2.73.7
IDeg0.03.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IDegLiraIDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.–7 / 19945 / 199
IDegInsulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).–11 / 19929 / 199

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

Studies7

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2019

6 results

EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES.

Lingvay et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 7

PMID 30383495DOI 10.4158/ep-2018-0284PUB-30383495

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2017

7 results

A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges.

King et al. 2017Diabetes technology & therapeuticscited by 18

PMID 28282219PMC5399738DOI 10.1089/dia.2016.0405PUB-28282219

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Indexing hint: Randomized controlled trial · 2014

5 results

Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira).

Buse et al. 2014Diabetes carecited by 204

PMID 25114296DOI 10.2337/dc14-0785PUB-25114296

Full text at the publisher5 results
Publisher pageSee results (5)

More studies

3 studies on this page

PubMed tag: none · 2017

Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden.

Å et al. 2017Applied health economics and health policycited by 27

PMID 28063135PMC5343072DOI 10.1007/s40258-016-0301-yPUB-28063135

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2017

Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program.

Khunti et al. 2017Diabetes therapy : research, treatment and education of diabetes and related disorders

PMID 28332144PMC5446379DOI 10.1007/s13300-017-0252-9PUB-28332144

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2016

Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone.

Vilsbøll et al. 2016Clinical drug investigationcited by 9

PMID 26894800PMC4801992DOI 10.1007/s40261-016-0376-0PUB-26894800

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects with type 2 diabetes * HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive) * Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label) * BMI (Body Mass Index) more than or equal to 27 kg/m\^2 Exclusion Criteria: * Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start * Impaired liver function * Impaired renal function * Screening calcitonin equal to or above 50 ng/l * Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) * Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures * Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg) * Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion * History of chronic pancreatitis or idiopathic acute pancreatitis

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