Phase 3
Completed N=435
The 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
Source: ClinicalTrials.gov NCT01618162 ↗Enrolled (actual)
435
Serious AEs
4.4%
Results posted
Feb 2017
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.45; -0.46 percentage of glycosylated haemoglobin — p=< 0.001
◆ Published Evidence
Highly cited
106citations · ~12 / year
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.
Summary
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.
Linked Publications (3)
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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.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.45; -0.46 | < 0.001 sig |
| SECONDARY Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) |
79.2; 28.8 | — |
| SECONDARY Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) |
64; 12.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-2.6; -0.31 | — |
| SECONDARY Change From Baseline in Body Weight |
0.5; -1 | — |
| SECONDARY Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes |
351.7; 135.2 | — |
| SECONDARY Number of Adverse Events (AEs) |
401.4; 367 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01618162) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.