LivingGLP1
Study S001276

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Registration

Registration
NCT01336023
Acronym
DUAL™ I
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
1663
Start
2011-05-23
Primary completion
2012-05-24
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes; Diabetes Mellitus, Type 2
Interventions
DRUG:insulin degludec/liraglutide; DRUG:insulin degludec; DRUG:liraglutide
Results posted
TRUE
Secondary identifiers
OTHER:U1111-1119-1174; EUDRACT_NUMBER:2010-021560-15

Registered primary outcomes

  • Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. [Week 0, week 26]

Linked records (10)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0010237Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Natale P, The Cochrane database of systematic reviews
2025Systematic reviewPMID 39963952DOIcites ClinicalTrials.gov:NCT01336023; registry reference DERIVED:39963952
R005029575-OR: In-Silico Replay of Insulin Degludec and Liraglutide Clinical Trial Data in Subjects with Type 2 Diabetes
MOHAMMADREZA GANJIARJENAKI, Diabetes
2024Other trialDOIcites ClinicalTrials.gov:NCT01336023
R0015570Rates 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 P, Diabetes, obesity & metabolism
2017OtherPMID 28417535DOIregistry reference RESULT:28417535
R0017641Efficacy 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 K, Diabetes therapy : research, treatment and education of diabetes and related disorders
2017Other trialPMID 28332144DOIcites ClinicalTrials.gov:NCT01336023; registry reference BACKGROUND:28332144
R0020281A 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 AB, Diabetes technology & therapeutics
2017Randomized trialPMID 28282219DOIcites ClinicalTrials.gov:NCT01336023; registry reference RESULT:28282219
R0021084Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone.
Vilsbøll T, Clinical drug investigation
2016OtherPMID 26894800DOIregistry reference RESULT:26894800
R0014347Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy.
Kapitza C, Journal of clinical pharmacology
2015Randomized trialPMID 25998481DOIregistry reference RESULT:25998481
R0018262IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test.
Holst JJ, Journal of diabetes science and technology
2015Randomized trialPMID 26443290DOIcites ClinicalTrials.gov:NCT01336023; registry reference RESULT:26443290
R0021244One-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 SC, Diabetes, obesity & metabolism
2015Randomized trialPMID 25980900DOIregistry reference RESULT:25980900
R0016819Efficacy 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 SC, The lancet. Diabetes & endocrinology
2014Randomized trialPMID 25190523DOIcites ClinicalTrials.gov:NCT01336023; registry reference RESULT:25190523