parallel randomized trial

NCT05013229

A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

Type 2 diabetes (adults)NCT05013229S001633

Design

Randomized: 679
Start year: 2021
Treatment: 52 weeks, follow-up 57 weeks
Countries: multinational (109 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: HbA1c 7.0 to 10.0 percent; basal insulin 20 to 80 U/day; BMI up to 40; eGFR 30 or more

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin icodec and semaglutide (IcoSema) subcutaneous once weekly titrated IcoSema	continued non insulin drugs except SU, glinides, DPP-4 inhibitors; lifestyle: not reported	340
A2	Basal bolus glargine aspart Glargine U100 plus aspart	continued non insulin drugs except SU, glinides, DPP-4 inhibitors; lifestyle: not reported	339

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Insulin icodec and semaglutide (IcoSema) subcutaneous once weekly titrated A1	Basal bolus glargine aspart A2
age egfr:<60	mean (years)	66.9	67.4
age egfr:<60	sd (years)	8.1	8.6
diabetes duration egfr:<60	mean (years)	15.93	15.89
diabetes duration egfr:<60	sd (years)	8.10	9.41
egfr egfr:<60	mean (mL/min/1.73 m2)	48.1	49.0
egfr egfr:<60	sd (mL/min/1.73 m2)	8.5	8.7
hba1c egfr:<60	mean (percent)	8.11	8.26
hba1c egfr:<60	sd (percent)	0.85	0.78
other male egfr:<60	n	22	18
other male egfr:<60	percent	61.1	58.1
other subgroup size egfr:<60	n	36	31
weight egfr:<60	mean (kg)	91.20	84.21
weight egfr:<60	sd (kg)	17.70	18.66

Results

2 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	16.7			6 /	not stated; other; egfr:<60; R0006474:Table 2
	A2	events	38.7			12 /	not stated; other; egfr:<60; R0006474:Table 2