Diabetes Obes MetabType 2 DiabetesRCTDecember 15, 2025

Insulin therapy DE-intensificAtion with iGlarLixi: A phase 4, open-label, parallel-group randomised controlled trial.

Novodvorský P, Thieme L, Laňková I, Franková Š, Veselá A, Záhumenský E, Edelsberger T, Löblová M, Žižka O, Vytasil M, Lauand F, Bonnemaire M, Hrubý F, Mráz M, Haluzík M

View on PubMed DOI: 10.1111/dom.70362

Key Finding

Switching from multiple daily insulin injections to once-daily iGlarLixi helped type 2 diabetes patients lose 4.2 kg while maintaining the same blood sugar control and cutting their insulin dose by nearly 29 units per day.

What This Study Found

Think of managing type 2 diabetes like juggling multiple balls - some patients have to inject insulin 3-4 times daily, constantly calculating doses and timing meals. This study tested whether people could switch from this complex routine to a simpler once-daily injection that combines two medications: basal insulin (like a steady drip keeping blood sugar stable) and a GLP-1 medication (like a brake pedal that slows digestion and reduces appetite). The researchers followed 90 people for 24 weeks, comparing those who switched to the combo injection versus those who stayed on their complex regimen. The remarkable finding was that the switch didn't hurt blood sugar control at all - both groups maintained identical HbA1c levels around 7.9%. But the combo group got significant bonuses: they lost over 9 pounds, needed nearly 30 fewer units of insulin daily, and spent less time with dangerously high blood sugars. It's like trading a manual transmission for an automatic - you get the same destination with much less work and some unexpected benefits along the way.

Statistics Decoded

HbA1c difference of -0.12% with confidence interval (-0.48, 0.23) means blood sugar control was essentially identical between groups - this range includes zero, so there's no meaningful difference. Weight loss of -4.19 kg (-5.95, -2.43) means the combo group lost between 5.4 and 13.1 pounds on average, and we're quite confident this wasn't just chance. The insulin dose reduction of -28.57 units daily is substantial - like going from taking 4-5 pills to just 2-3 pills of a different medication. Time in 'level 2 hyperglycaemia' dropped by 4.9%, meaning they spent about 70 fewer minutes per day with dangerously high blood sugar (over 250 mg/dL). The study included people averaging 66 years old with diabetes for 17.5 years and BMI of 33.6 (obese category).

Why This Matters

This gives doctors and patients a compelling option to simplify diabetes management without sacrificing control - fewer injections, significant weight loss, and lower insulin requirements could dramatically improve quality of life and reduce the burden of diabetes care. For the many type 2 diabetes patients struggling with complex insulin regimens, this represents a potential path to both simplification and better metabolic outcomes.

Original Abstract

To evaluate the efficacy and safety of transitioning from multiple daily injections (MDIs) insulin regimen to once-daily, fixed-ratio combination of basal insulin analog glargine 100 U/mL and a glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) in people with type 2 diabetes (PwT2D). Insulin therapy DE-intensificAtion with iglarLixi was a five-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period. Eligible PwT2D (age 18-80 years, HbA1c ≤9% [75 mmol/mol], total daily dose of insulin ≤0.8 IU/kg, and fasting C-peptide above the lower limit of normal) were randomised in a 1:1 fashion to iGlarLixi initiation or continuation with MDI regimen. The primary endpoint was the mean change in HbA1c from baseline to 24 weeks after randomisation between the two treatment groups. Ninety individuals (n = 45 in both treatment groups), 71/91 (79.0%) male with mean (SD) age 66.2 (8.7) years, HbA1c 7.9 (1.0) % (62.8 [10.9] mmol/mol), diabetes duration 17.5 (8.7) years and body mass index (BMI) 33.6 (5.5) kg/m2 were analysed. The mean (95% confidence interval) difference in the change in HbA1c between the iGlarLixi and the MDI group was -0.12 (-0.48, 0.23)% (-1.39 [-5.21, 2.43] mmol/mol), indicating comparable glycaemic control in both treatment groups. Significant between-group differences in favour of iGlarLixi were observed in body weight: -4.19 (-5.95, -2.43) kg, BMI: -1.49 (-2.11, -0.86) kg/m2, total daily dose of insulin: -28.57 (-34.89, -22.24) IU, time spent in level 2 hyperglycaemia: -4.9 (-9.4, -0.34)%, and glycaemia risk index: -13.6 (-25.1, -2.1). Insulin therapy simplification from MDI regimen to once-daily iGlarLixi is an efficient and safe treatment option for PwT2D.