Primary outcomeMean· Week 0, Week 26
Change in Glycosylated Haemoglobin (HbA1c)
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| IDegLira | -1.45 | 0.84 |
| Placebo | -0.46 | 0.83 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataThe Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
Short name DUAL™IV
NCTNCT01618162 (opens ClinicalTrials.gov in a new tab)Other idNN9068-3951Other id2012-000140-97Other idU1111-1126-9776
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 435 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
8 countries
United States, Bulgaria, Canada, Germany, India, Israel, Puerto Rico, Turkey (Türkiye)
- Start
- 29 Aug 2012
- Primary completion
- 23 Oct 2013
- Completion
- 23 Oct 2013
- First posted
- 13 Jun 2012 (estimated)
- Last update posted
- 27 Oct 2017
- 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
201220132014
- Ph 3
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 investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Interventions
- insulin degludec/liraglutideDrug
- placeboDrug
Arms2
Experimental
Insulin degludec/liraglutide
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Haemoglobin (HbA1c)
Time frame · Week 0, Week 26
Registry description
Change in HbA1c from baseline to 26 weeks.
Secondary outcomes(6)
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Time frame · Week 26
Registry description
Percentage of subjects having HbA1c below 7% at week 26.
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time frame · Week 26
Registry description
Percentage of subjects having HbA1c below 6.5% at week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 26
Registry description
Change from baseline in FPG at week 26.
Change From Baseline in Body Weight
Time frame · Week 0, week 26
Registry description
Change from baseline in body weight at week 26.
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
Time frame · After 26 weeks of treatment
Registry description
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
Number of Adverse Events (AEs)
Time frame · After 26 weeks of treatment
Registry description
An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 26
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
| Group | Value (percentage of subjects) |
|---|---|
| IDegLira | 79.2 |
| Placebo | 28.8 |
Secondary outcomeNumber· Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
| Group | Value (percentage of subjects) |
|---|---|
| IDegLira | 64 |
| Placebo | 12.3 |
Secondary outcomeMean· Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| IDegLira | -2.6 | 2.61 |
| Placebo | -0.31 | 2.43 |
Secondary outcomeMean· Week 0, week 26
Change From Baseline in Body Weight
| Group | Value (kilogram) | Spread |
|---|---|---|
| IDegLira | 0.5 | 3.1 |
| Placebo | -1 | 2.6 |
Secondary outcomeNumber· After 26 weeks of treatment
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
| Group | Value (event rate per 100 PYE) |
|---|---|
| IDegLira | 351.7 |
| Placebo | 135.2 |
Secondary outcomeNumber· After 26 weeks of treatment
Number of Adverse Events (AEs)
| Group | Value (event rate per 100 PYE) |
|---|---|
| IDegLira | 401.4 |
| Placebo | 367 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| IDegLiraIn this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L). | – | 14 / 288 | 83 / 288 |
| PlaceboIn this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L). | – | 5 / 146 | 38 / 146 |
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.
Studies with results
2 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
Indexing hint: Randomized controlled trial · 2017
5 results
Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with Type 2 diabetes: the DUAL IV trial.
Rodbard et al. 2017Diabetic medicine : a journal of the British Diabetic Associationcited by 87
PMID 27589252PMC5811787DOI 10.1111/dme.13256PUB-27589252
Free to read · publisher termsCC BY-NC-ND5 results
More studies
1 study 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
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
* HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
* Body Mass Index (BMI) below or equal to 40 kg/m\^2
Exclusion Criteria:
* Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
* Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
* 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 above or equal to 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 clinical 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 product
* History of chronic pancreatitis or idiopathic acute pancreatitis
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