Phase 3
Completed N=506
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02420262 ↗Enrolled (actual)
506
Serious AEs
4.4%
Results posted
Dec 2017
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin) — -1.48; -1.46 Percentage of glycosylated haemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
187citations · ~23 / year
Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial.
Summary
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.
Linked Publications (3)
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Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial.
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The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial.
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Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin) |
-1.48; -1.46 | <0.0001 sig |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes. |
129; 975 | <0.0001 sig |
| SECONDARY Change in Body Weight |
-0.93; 2.64 | <0.0001 sig |
| SECONDARY Responder for HbA1c Below 7.0% |
157; 156; 81; 77 | — |
| SECONDARY Responder for HbA1c Below or Equal to 6.5 % |
118; 104; 120; 129 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age at least 18 years at the time of signing informed consent
- Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
- HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
- Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
- Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
- Body mass index (BMI) below or equal to 40 kg/m^2
Exclusion Criteria
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
- Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
- Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
- Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Screening calcitonin at least 50 ng/L
- History of pancreatitis (acute or chronic)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Data sourced from ClinicalTrials.gov (NCT02420262) 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.