Phase 3 · Liraglutide

DUAL III trial results

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 (DUAL™ III -GLP-1 Switch)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) (percentage of glycosylated haemoglobin), Week 0, week 26. Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs): -1.32; Liraglutide or Exenatide + OADs: -0.37.

Participants
438
Status
completed
Completed
2014-03-11
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01676116), updated at source Jan 3, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What DUAL III measured first

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)percentage of glycosylated haemoglobin · Week 0, week 26 · least squares mean
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292Liraglutide or Exenatide + OADsn=146
-1.32(0.05)-0.37(0.07)
Side effects by arm

Side effects in DUAL III

Percent of participants affected, Adverse events from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (week 27) are reported.. The most common events the registry lists.

EventInsulin Degludec/Liraglutide +OADsLiraglutide or Exenatide + OADs
Any serious event3.1%2.1%
Nasopharyngitis8.9%13.1%
Lipase increased10%4.8%
Headache9.3%6.2%
Upper respiratory tract infection6.2%5.5%
Diarrhoea4.5%5.5%
Secondary outcomes

What else it measured

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)Percentage · Week 26 · number
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292Liraglutide or Exenatide + OADsn=146
75.335.6
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)Percentage · Week 26 · number
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292Liraglutide or Exenatide + OADsn=146
6322.6
Change From Baseline in Body Weightkg · Week 0, week 26 · mean
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=292Liraglutide or Exenatide + OADsn=146
2(3.9)-0.8(3.0)
Change From Baseline in Fasting Plasma Glucose (FPG)mmol/L · Week 0, week 26 · mean
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=285Liraglutide or Exenatide + OADsn=145
-2.98(2.28)-0.6(2.74)
Number of Severe or Minor Hypoglycaemic Episodesevents per 100 patient years of exposure · After 26 weeks of treatment · number
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=291Liraglutide or Exenatide + OADsn=145
281.712.1
Number of Adverse Events (AEs)events per 100 exposure years · After 26 weeks of treatment · number
Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=291Liraglutide or Exenatide + OADsn=145
410.1364.3
Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)Scores on a scale · Week 0, week 26 · mean
MeasureInsulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=290Liraglutide or Exenatide + OADsn=146
TRIM-D Treatment Burden Score10.8(18.8)5.7(19.3)
TRIM-D Daily Life Score6.3(18.4)0.8(18.2)
TRIM-D Diabetes Management Score10.9(21.3)4.1(19.8)
TRIM-D Compliance Score8.9(17.3)4.3(15.9)
TRIM-D Psychological Health Score7.3(14.7)1.4(16.5)
TRIM-D Total Score8.7(12)3.1(12.2)
Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).Scores on a scale · Week 0, week 26 · mean
MeasureInsulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs)n=290Liraglutide or Exenatide + OADsn=146
Treatment satisfaction scale total3.1(5.6)1.1(5.0)
Hyperglycaemia-1.8(2.1)-0.6(1.9)
Hypoglycaemia0.2(1.7)-0.1(1.5)
The trial

How DUAL III was run

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.

  • Insulin degludec/liraglutide + OADs
  • Liraglutide or exenatide + OADs
Who could join the trial

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

Published papers

Papers from DUAL III

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.