Phase 3
Completed N=438
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
Source: ClinicalTrials.gov NCT01676116 ↗Enrolled (actual)
438
Serious AEs
2.8%
Results posted
Jul 2018
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) — -1.32; -0.37 percentage of glycosylated haemoglobin — p=<0.001
◆ Published Evidence
Highly cited
134citations · ~15 / year
The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial.
Summary
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.
Linked Publications (3)
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The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial.
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EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) |
-1.32; -0.37 | <0.001 sig |
| SECONDARY Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) |
75.3; 35.6 | — |
| SECONDARY Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) |
63; 22.6 | — |
| SECONDARY Change From Baseline in Body Weight |
2; -0.8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-2.98; -0.6 | — |
| SECONDARY Number of Severe or Minor Hypoglycaemic Episodes |
281.7; 12.1 | — |
| SECONDARY Number of Adverse Events (AEs) |
410.1; 364.3 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D) |
10.8; 5.7; 6.3; 0.8; 10.9; 4.1 | — |
| SECONDARY Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ). |
3.1; 1.1; -1.8; -0.6; 0.2; -0.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01676116) 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.