Primary outcome
What DUAL measured first
| IDegLiran=16 | IDegLira + IAspn=15 |
|---|---|
| -0.43(0.94) | -0.14(1.09) |
Phase 3 · Liraglutide
DUAL trial results
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™ - Intensification)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (Percentage of glycosylated haemoglobin), Week 0, week 26. IDegLira: -0.43; IDegLira + IAsp: -0.14.
- Participants
- 31
- Status
- completed
- Completed
- 2015-04
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT02100475), updated at source Jan 20, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in DUAL
Percent of participants affected, From first trial-related activity (week 0) after the subject had signed the informed consent until the end of the post-treatment follow-up period (week 27).. The most common events the registry lists.
| Event | IDegLira | IDegLira + IAsp |
|---|---|---|
| Any serious event | 6.3% | 13.3% |
| Abdominal pain | 0% | 6.7% |
| Amylase increased | 0% | 6.7% |
| Asthma | 0% | 6.7% |
| Back pain | 6.3% | 6.7% |
| Cardiac murmur | 0% | 6.7% |
| Diarrhoea | 0% | 6.7% |
| Hyperkalaemia | 0% | 6.7% |
| Lipase increased | 6.3% | 6.7% |
| Oedema peripheral | 0% | 6.7% |
| Renal cyst | 0% | 6.7% |
| Upper respiratory tract infection | 0% | 6.7% |
| Anaemia | 6.3% | 0% |
| Blood calcitonin increased | 6.3% | 0% |
| Bronchitis | 6.3% | 0% |
| Dyslipidaemia | 6.3% | 0% |
| Headache | 6.3% | 0% |
| Hypertension | 6.3% | 0% |
| Insomnia | 6.3% | 0% |
| Macular degeneration | 6.3% | 0% |
| Neuropathy peripheral | 6.3% | 0% |
| Pain in extremity | 6.3% | 0% |
| Sciatica | 6.3% | 0% |
| Seborrhoeic dermatitis | 6.3% | 0% |
| Tendonitis | 6.3% | 0% |
| Tooth disorder | 6.3% | 0% |
Secondary outcomes
What else it measured
| IDegLiran=16 | IDegLira + IAspn=15 |
|---|---|
| 0.9(2.1) | 1.5(3.2) |
| IDegLiran=16 | IDegLira + IAspn=15 |
|---|---|
| 34 | 4 |
The trial
How DUAL was run
This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).
- Insulin degludec/liraglutide + Metformin
- Insulin degludec/liraglutide + Insulin Aspart + Metformin
Who could join the trial
Inclusion Criteria: * Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin * HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial Exclusion Criteria: * Clinically significant diseases of the major organ systems * Screening calcitonin above or equal to 50 ng/L
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.