Phase 3
Completed N=31
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
Source: ClinicalTrials.gov NCT02100475 ↗Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — -0.43; -0.14 Percentage of glycosylated haemoglobin — p=0.427
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
-0.43; -0.14 | 0.427 |
| SECONDARY Change From Baseline in Body Weight |
0.9; 1.5 | — |
| SECONDARY Number of Treatment-emergent Confirmed Hypoglycaemic Episodes |
34; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02100475). 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.