Xultophy 100/3.6 is a long-acting insulin and a GLP-1 drug sharing one pen. The insulin is degludec (the insulin in Tresiba); the GLP-1 drug is liraglutide, the molecule in Victoza. It is a once-daily injection for adults with type 2 diabetes, approved in the United States in November 2016, and federal records still list it as a prescription product. Its trials showed lower blood sugar than either component alone, with weight roughly flat.
This page reads the current Novo Nordisk label (effective 14 October 2025, the most recent on DailyMed), the FDA application record and the trials the label cites. Records were read on 17 October 2026. It reports what the documents say; it does not advise on treatment.
Status: approved, listed, still labelled
| Record | What it shows | Read |
|---|---|---|
| Drugs@FDA, BLA 208583 | Xultophy 100/3.6, Novo Nordisk; original approval 21 November 2016; marketing status Prescription; 16 submissions, the latest a labelling supplement approved 14 October 2025 | openFDA, 2026-10-17 (data updated 2026-10-16) |
| DailyMed | One current label, Novo Nordisk, SPL version 14, effective 2025-10-14 | 2026-10-17 |
An earlier note on this site's Soliqua page recorded the same Prescription status on 14 October. Neither record says how widely the pen is stocked or which plans cover it.
What is in the pen
Each millilitre holds 100 units of insulin degludec and 3.6 mg of liraglutide. The label counts Xultophy in units, and every unit carries both drugs in that fixed ratio: the pen delivers 10 to 50 units a day, and 50 units is 1.8 mg of liraglutide — the same as Victoza's highest dose. Because the two move together, the insulin amount cannot be changed without changing the liraglutide amount.
The label's limitations of use: not with any other product containing liraglutide or another GLP-1 drug, and not for diabetic ketoacidosis. It is approved for blood-sugar control in adults with type 2 diabetes; unlike Victoza, it carries no cardiovascular indication and no approval for children.
The six trials on the label
The label reports six randomised, 26-week phase 3 trials with 3,908 patients in total. Each compared Xultophy with a different alternative.
| Trial (registry) | Who | Comparator | HbA1c change: Xultophy vs comparator | HbA1c <7% |
|---|---|---|---|---|
| NCT01336023 (DUAL I) | 1,660 on metformin ± pioglitazone | Insulin degludec alone; liraglutide alone | -1.81 vs -1.35 and -1.21 | 74.1% vs 60.5% and 56% |
| NCT01618162 | 435 on a sulfonylurea ± metformin | Placebo (double-blind) | -1.42 vs -0.62 | 70.9% vs 26.7% |
| NCT01392573 (double-blind) | 398 on basal insulin and metformin | Insulin degludec (capped at 50 units) | -1.94 vs -1.05 | 57.3% vs 22.6% |
| NCT01952145 (DUAL V) | 557 on metformin, already on insulin glargine | Insulin glargine U-100 | -1.67 vs -1.16 | 68.3% vs 46.2% |
| NCT01676116 | 348 already on liraglutide | Continued liraglutide up to 1.8 mg | -1.31 vs -0.36 | 74.6% vs 30.2% |
| NCT02773368 | 420 on an SGLT-2 inhibitor | Insulin glargine U-100 (no dose cap) | -1.97 vs -1.59 | 79.5% vs 68.6% |
Source: Xultophy 100/3.6 label, section 14, read 2026-10-17. HbA1c in percentage points, least-squares means. The label marks the insulin degludec comparator in NCT01392573 as capped at a maximum of 50 units, the same ceiling as Xultophy; in NCT02773368 the glargine dose had no cap. Trial acronyms from the registry records.
What the comparisons can and cannot say. Four of the six trials were open-label. Against an insulin whose dose was capped at Xultophy's own ceiling, Xultophy's advantage was large (-0.89 points); against glargine with no ceiling, it was smaller (-0.38). The design choice matters to the size of the result, and the label states it for each trial.
Weight and low blood sugar
The label's clinical-studies tables do not report weight. The registry records do:
| Trial | Xultophy | Comparator(s) |
|---|---|---|
| NCT01336023 (DUAL I), 26 weeks | -0.5 kg | insulin degludec +1.6 kg; liraglutide -3.0 kg |
| NCT01952145 (DUAL V), 26 weeks | -1.4 kg | insulin glargine +1.8 kg |
ClinicalTrials.gov posted results, read 2026-10-17.
So the pen's effect on weight sat between its components: better than insulin alone, worse than liraglutide alone. The label adds the other direction: in its switching trial, people moving from liraglutide to Xultophy gained a mean 2 kg in 26 weeks, which it attributes to insulin's anabolic effect.
Low blood sugar follows the same logic. In DUAL I, confirmed hypoglycaemic events ran at 1.8 per patient-year on Xultophy, against 2.6 on insulin degludec alone and 0.2 on liraglutide alone (Gough et al., 2014). Nausea was 8.8% on Xultophy against 19.7% on liraglutide and 3.6% on insulin degludec.
Side effects
| Reaction (label Table 3) | % of Xultophy-treated patients |
|---|---|
| Nasopharyngitis | 10 |
| Headache | 9 |
| Nausea | 8 |
| Diarrhoea | 8 |
| Upper respiratory tract infection | 6 |
The label describes hypoglycaemia as the most common reaction with insulin-containing products. Because it contains liraglutide, it carries liraglutide's boxed warning on thyroid C-cell tumours, and its warnings include pancreatitis, severe gastrointestinal reactions (it is not recommended in severe gastroparesis), kidney injury from dehydration and gallbladder disease. The class-wide record on the thyroid warning is on GLP-1 drugs and thyroid cancer.
Xultophy and Soliqua
| Xultophy 100/3.6 | Soliqua 100/33 | |
|---|---|---|
| Maker | Novo Nordisk | Sanofi |
| Insulin | Degludec, 100 units/mL | Glargine, 100 units/mL |
| GLP-1 drug | Liraglutide, 3.6 mg/mL | Lixisenatide, 33 mcg/mL |
| Daily range | 10–50 units | 15–60 units |
| Same GLP-1 sold alone in the US | Yes (Victoza and generic liraglutide) | Only inside Soliqua on DailyMed |
The two use different insulins, different GLP-1 drugs and different unit scales, so a unit of one is not a unit of the other. No trial has compared them head to head. The Soliqua record, including the LixiLan trials, is on Soliqua; liraglutide on its own is on Victoza.
What is not established
- Heart outcomes. Xultophy has no cardiovascular-outcome trial of its own on its label; Victoza's LEADER result is not part of Xultophy's indication.
- Use beyond 26 weeks in the label's efficacy tables.
- Price. No dated list price from Novo Nordisk was read for this page.
- How it compares with a separate insulin plus a weekly GLP-1 such as Ozempic; none of the label's trials tested that.
Whether a combination pen, separate injections, or neither suits a person with type 2 diabetes is a decision for their diabetes clinician. The full class is set out on which drugs are GLP-1s.
Sources
- XULTOPHY 100/3.6 (insulin degludec and liraglutide) injection, Novo Nordisk, label effective 2025-10-14, SPL version 14 (set ID 21335fe4-d395-4501-ac2a-2f20d7520da9), sections 1, 2, 5, 6.1 (Table 3) and 14, dailymed.nlm.nih.gov, read 2026-10-17.
- FDA Drugs@FDA, BLA 208583, via openFDA, read 2026-10-17 (dataset updated 2026-10-16).
- ClinicalTrials.gov posted results: NCT01336023 and NCT01952145, read 2026-10-17.
- Gough SCL et al. "Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone (DUAL I)." Lancet Diabetes Endocrinol 2014, PubMed 25190523.