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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name DUAL™ I

NCTNCT01336023 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3697Other idU1111-1119-1174Other id2010-021560-15
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,663 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
20 countries

United States, Australia, Canada, Finland, Germany, Hungary, India, Ireland, Italy, Malaysia, Mexico, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom

Start
23 May 2011
Primary completion
24 May 2012
Completion
22 Nov 2012
First posted
15 Apr 2011 (estimated)
Last update posted
19 Feb 2018
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™ I

    NCT01336023

    23 May 2011 to 22 Nov 2012

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 this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin degludecDrug
  • liraglutideDrug

Arms3

  • Experimental

    IDeg

  • Experimental

    IDegLira

  • Experimental

    Lira

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

    Time frame · Week 0, week 26

    Registry description

    Values of mean change in HbA1c.

Secondary outcomes(4)

  1. Mean Change From Baseline in Body Weight at Week 26

    Time frame · Week 0, Week 26

    Registry description

    Values of mean change in body weight.

  2. Number of Hypoglycaemic Episodes

    Time frame · Weeks 0-26

    Registry description

    Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.

  3. Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

    Time frame · Week 0, Week 26

    Registry description

    Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.

  4. Mean Actual Daily Insulin Dose

    Time frame · Week 26

    Registry description

    Mean of the actual doses recorded at visit 28 (Week 26).

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

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.

GroupValue (Percentage of glycosylated haemoglobin)Spread
IDeg-1.441.03
IDegLira-1.911.07
Liraglutide-1.281.13
Secondary and other outcome results(4)
Secondary outcomeMean· Week 0, Week 26

Mean Change From Baseline in Body Weight at Week 26

GroupValue (kg)Spread
IDeg1.64.0
IDegLira-0.53.5
Liraglutide-3.03.5
Secondary outcomeNumber· Weeks 0-26

Number of Hypoglycaemic Episodes

GroupValue (Events per 100 patient years of exposure)
IDeg256.7
IDegLira180.2
Liraglutide22.0
Secondary outcomeMean· Week 0, Week 26

Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test

GroupValue (mmol/L)Spread
IDeg-0.171.98
IDegLira-0.871.65
Liraglutide-0.781.62
Secondary outcomeMean· Week 26

Mean Actual Daily Insulin Dose

GroupValue (units)Spread
IDeg5328
IDegLira3813

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IDegInsulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.–22 / 412160 / 412
IDegLiraInsulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.–38 / 825386 / 825
LiraglutideLiraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.–24 / 412241 / 412

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

Studies9

Studies that cite this trial.

Studies with results

7 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 · 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: Observational study · 2017

4 results

Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used.

Norwood et al. 2017Diabetes, obesity & metabolismcited by 3

PMID 28417535PMC5655847DOI 10.1111/dom.12972PUB-28417535

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2015

13 results

One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.

Gough et al. 2015Diabetes, obesity & metabolismcited by 97

PMID 25980900PMC4744775DOI 10.1111/dom.12498PUB-25980900

Free to read · publisher termsCC BY-NC-ND13 results
Read at sourceSee results (13)

Indexing hint: Randomized controlled trial · 2015

4 results

Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy.

Kapitza et al. 2015Journal of clinical pharmacologycited by 23

PMID 25998481DOI 10.1002/jcph.549PUB-25998481

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2015

8 results

IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test.

Holst et al. 2015Journal of diabetes science and technologycited by 21

PMID 26443290PMC4773967DOI 10.1177/1932296815610124PUB-26443290

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2014

14 results

Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.

Gough et al. 2014The lancet. Diabetes & endocrinologycited by 264

PMID 25190523DOI 10.1016/s2213-8587(14)70174-3PUB-25190523

Full text at the publisher14 results
Publisher pageSee results (14)

More studies

2 studies on this page

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 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% * Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital) * Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening * Body Mass Index (BMI) maximum 40 kg/m\^2 Exclusion Criteria: * Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) * Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial * Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) * Screening calcitonin at least 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 12 months and planned coronary, carotid or peripheral artery revascularisation procedures * Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg) * Acute treatment required proliferative retinopathy or maculopathy (macular oedema) * History of chronic pancreatitis or idiopathic acute pancreatitis

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