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Trial · Interventional

CompletedPhase 3Results postedRegistry data

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

Short name DUAL™ III

NCTNCT01676116 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3851Other id2012-000209-63Other idU1111-1127-1321

Overview

Status
Completed
Phase
Phase 3
Enrollment
438 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

United States, Australia, France, Hungary, Slovakia

Start
29 Aug 2012
Primary completion
11 Mar 2014
Completion
11 Mar 2014
First posted
30 Aug 2012 (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
2012201320142015
  1. Ph 3

    DUAL™ III

    NCT01676116

    29 Aug 2012 to 11 Mar 2014

Registry summary

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

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Interventions

  • insulin degludec/liraglutideDrug
  • liraglutideDrug
  • exenatideDrug

Arms2

  • Experimental

    Insulin degludec/liraglutide + OADs

  • Active comparator

    Liraglutide or exenatide + OADs

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)

    Time frame · Week 0, week 26

Secondary outcomes(8)
  1. Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

    Time frame · Week 26

    Registry description

    Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.

  2. Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

    Time frame · Week 26

    Registry description

    Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).

  3. Change From Baseline in Body Weight

    Time frame · Week 0, week 26

    Registry description

    Mean change in body weight after 26 weeks of treatment.

  4. Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, week 26

    Registry description

    Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.

  5. Number of Severe or Minor Hypoglycaemic Episodes

    Time frame · After 26 weeks of treatment

    Registry description

    Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or PG \<3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or PG value \<3.1 mmol/L (56 mg/dL).

  6. Number of Adverse Events (AEs)

    Time frame · After 26 weeks of treatment

    Registry description

    Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.

  7. Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)

    Time frame · Week 0, week 26

    Registry description

    The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.

  8. Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).

    Time frame · Week 0, week 26

    Registry description

    Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.

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 outcomeLeast squares mean· Week 0, week 26

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)

GroupValue (percentage of glycosylated haemoglobin)Spread
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)-1.320.05
Liraglutide or Exenatide + OADs-0.370.07
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 26

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)

GroupValue (Percentage)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)75.3
Liraglutide or Exenatide + OADs35.6
Secondary outcomeNumber· Week 26

Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)

GroupValue (Percentage)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)63
Liraglutide or Exenatide + OADs22.6
Secondary outcomeMean· Week 0, week 26

Change From Baseline in Body Weight

GroupValue (kg)Spread
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)23.9
Liraglutide or Exenatide + OADs-0.83.0
Secondary outcomeMean· Week 0, week 26

Change From Baseline in Fasting Plasma Glucose (FPG)

GroupValue (mmol/L)Spread
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)-2.982.28
Liraglutide or Exenatide + OADs-0.62.74
Secondary outcomeNumber· After 26 weeks of treatment

Number of Severe or Minor Hypoglycaemic Episodes

GroupValue (events per 100 patient years of exposure)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)281.7
Liraglutide or Exenatide + OADs12.1
Secondary outcomeNumber· After 26 weeks of treatment

Number of Adverse Events (AEs)

GroupValue (events per 100 exposure years)
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)410.1
Liraglutide or Exenatide + OADs364.3
Secondary outcomeMean· Week 0, week 26

Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)

GroupValue (Scores on a scale)Spread
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)10.818.8
Liraglutide or Exenatide + OADs5.719.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin Degludec/Liraglutide +OADsSubjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Insulin degludec/liraglutide was dosed on an individual basis. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern.–9 / 29188 / 291
Liraglutide or Exenatide + OADsSubjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern.–3 / 14539 / 145

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

Studies3

Studies that cite this trial.

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

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

Rights unknown15 results

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

More studies

1 study on this page

PubMed tag: none · 2017

The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial.

Linjawi et al. 2017Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 113

PMID 27943107PMC5306117DOI 10.1007/s13300-016-0218-3PUB-27943107

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 mellitus * Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive) * Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1) * BMI (body mass index) equal to or below 40 kg/m\^2 Exclusion Criteria: * Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1) * Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids) * Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator) * Screening calcitonin equal to or above 50 ng/l * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) * Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures * Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion * Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products * History of chronic pancreatitis or idiopathic acute pancreatitis

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