Primary outcomeLeast squares mean· Week 0, Week 26
Change in HbA1c (Glycosylated Haemoglobin)
| Group | Value (Percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| IDegLira | -1.48 | 0.05 |
| IGlar + IAsp | -1.46 | 0.05 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
NCTNCT02420262 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4185Other id2014-003621-18Other idU1111-1160-6923Other idREec-2015-1682
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 506 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
12 countries
United States, Argentina, Czechia, France, Greece, Hungary, Israel, Mexico, Russia, Slovakia, Spain, Turkey (Türkiye)
- Start
- 26 Jul 2015
- Primary completion
- 5 Oct 2016
- Completion
- 5 Oct 2016
- First posted
- 17 Apr 2015 (estimated)
- Last update posted
- 29 Mar 2018
- 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
201520162017
- Ph 3
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
NCT0242026226 Jul 2015 to 5 Oct 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- insulin degludec/liraglutideDrug
- insulin glargineDrug
- insulin aspartDrug
Arms2
Experimental
IDegLira
Active comparator
IGlar plus IAsp
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c (Glycosylated Haemoglobin)
Time frame · Week 0, Week 26
Registry description
Change in HbA1c values after 26 weeks of treatment.
Secondary outcomes(4)
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
Time frame · Weeks 0-26
Registry description
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
Change in Body Weight
Time frame · Week 0, Week 26
Registry description
Change in body weight after 26 weeks of treatment.
Responder for HbA1c Below 7.0%
Time frame · After 26 weeks of treatment
Registry description
Number of subjects with HbA1c below 7% after 26 weeks of treatment.
Responder for HbA1c Below or Equal to 6.5 %
Time frame · After 26 weeks of treatment
Registry description
Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.
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(4)
Secondary outcomeNumber· Weeks 0-26
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
| Group | Value (Number of episodes) |
|---|---|
| IDegLira | 129 |
| IGlar + IAsp | 975 |
Secondary outcomeLeast squares mean· Week 0, Week 26
Change in Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| IDegLira | -0.93 | 0.22 |
| IGlar + IAsp | 2.64 | 0.22 |
Secondary outcomeCount of participants· After 26 weeks of treatment
Responder for HbA1c Below 7.0%
| Group | Value (Participants) |
|---|---|
| IDegLira | 157 |
| IGlar + IAsp | 156 |
Secondary outcomeCount of participants· After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %
| Group | Value (Participants) |
|---|---|
| IDegLira | 118 |
| IGlar + IAsp | 104 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| IDegLiraInsulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern. | – | 12 / 252 | 84 / 252 |
| IGlar + IAspSubjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L). | – | 10 / 253 | 79 / 253 |
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: Randomized controlled trial · 2021
10 results
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.
Billings et al. 2021Journal of diabetes science and technologycited by 7
PMID 32107930PMC8120051DOI 10.1177/1932296820906888PUB-32107930
Rights unknown10 results
Indexing hint: Randomized controlled trial · 2018
7 results
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.
Billings et al. 2018Diabetes carecited by 142
PMID 29483185DOI 10.2337/dc17-1114PUB-29483185
Full text at the publisher7 results
More studies
1 study on this page
PubMed tag: none · 2020
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.
Meneghini et al. 2020Diabetic medicine : a journal of the British Diabetic Associationcited by 5
PMID 31705547PMC7003817DOI 10.1111/dme.14178PUB-31705547
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:
* 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
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