Significant blood sugar improvement with Xultophy® 100/3.6 compared to insulin glargine U-100 when

DUAL IX was a phase 3b, 26-week, open-label clinical trial that compared Xultophy® 100/3.6 to insulin glargine U-100 in adults with type 2 diabetes uncontrolled on SGLT-2i treatment, with or without other oral antidiabetic drugs.1 Xultophy® 100/3.6 is not indicated for use as an add-on to oral diabetes medications.

Results from some of the secondary endpoints in DUAL IX included change from baseline in body weight, severe or blood glucose confirmed symptomatic hypoglycaemic events and daily insulin dose at 26 weeks. Mean body weight remained unchanged in the Xultophy® 100/3.6 study group versus a 2.0 kg (4.4 lb) weight gain with insulin glargine U-100.1 Treatment with Xultophy® 100/3.6 demonstrated a 58% lower rate of hypoglycaemia versus insulin glargine U-100 (0.37 events/patient-year of exposure vs 0.90 events/patient-year of exposure respectively; p=0.0035). The average total daily insulin dose was significantly less with Xultophy® 100/3.6 than insulin glargine U-100 (36 units per day vs 54 units per day respectively; p˂0.0001).

“Type 2 diabetes is a progressive disease that often requires treatment intensification,” said Dr. Athena Philis-Tsimikas, DUAL IX lead investigator and corporate vice president, Scripps Whittier Diabetes Institute. “Xultophy® 100/3.6 may be an appropriate treatment option for those adults who are unable to meet their blood sugar goals on their current medication.”

Adverse events were similar across both treatment groups; the most common adverse events (≥5%) in the Xultophy® 100/3.6 treated patients included viral upper respiratory tract infection, headaches, back pain, increased lipase, and nausea. The safety profile of Xultophy® 100/3.6 in DUAL IX was consistent with previous Xultophy® 100/3.6 clinical trials.1

Additional DUAL IX patient-reported outcomes were presented at the meeting:

  • Patient-Reported Outcomes for Insulin Degludec/Liraglutide (IDegLira) vs Insulin Glargine (IGlar U-100) as Add-On to Sodium-Glucose Co-Transporter-2 Inhibitor (SGLT2i) ± Oral Antidiabetic Drug (OAD) Therapy in Patients with Type 2 Diabetes: DUAL IX Trial (Poster Presentation 101-LB)

About DUAL IX 
DUAL IX was a phase 3b, 26-week, randomised, open-label, multicentre trial conducted in 11 countries including 420 patients. The trial was designed to investigate the safety and efficacy of Xultophy® 100/3.6 versus insulin glargine U-100 as add-on therapy in adults uncontrolled on sodium-glucose co-transporter-2 inhibitor (SGLT-2i) treatment with or without additional oral antidiabetic drug therapy.2 A hypoglycaemic event in DUAL IX was defined as an event requiring assistance from another person or blood glucose (BG) confirmed (less than 56 mg/dL) with symptoms consistent with hypoglycaemia.

About Xultophy® 100/3.6 
Xultophy® 100/3.6 is a combination of insulin degludec, a long-acting human insulin analogue, and liraglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).3

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