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A 40-week study comparing the efficacy, safety and patient-reported outcomes of once weekly IcoSema and once or twice daily insulin degludec/insulin aspart 100 units/mL, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily pre-mixed insulin. COMBINE 5

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521150-42-00
Acronym
NN1535-8377
Enrollment
72
Registered
2025-12-09
Start date
Unknown
Completion date
2025-12-09
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Brief summary

Change in HbA1c

Detailed description

Change in body weight, Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Weekly insulin dose (total), Change in DTSQs total treatment satisfaction, Change in HbA1c, Change in mean 7-point SMPG profiles, Change in mean post-prandial glucose increment (over all meals), Time spent < 3.0 mmol/L (54 mg/dL), Time spent > 10.0 mmol/L (180 mg/dL), Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL), Change in FPG, Change in Treatment Related Impact Measure - Diabetes (TRIM-D) score, Change in EQ-5D-5L score, Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL], confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3)

Interventions

DRUGRyzodeg 100 units/mL FlexTouch solution for injection in pre-filled pen
DRUGIcoSema 700 U/mL + 2 mg/mL PDS290

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in HbA1c—

Secondary

MeasureTime frame
Change in body weight, Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3), Weekly insulin dose (total), Change in DTSQs total treatment satisfaction, Change in HbA1c, Change in mean 7-point SMPG profiles, Change in mean post-prandial glucose increment (over all meals), Time spent < 3.0 mmol/L (54 mg/dL), Time spent > 10.0 mmol/L (180 mg/dL), Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL), Change in FPG, Change in Treatment Related Impact Measure - Diabetes (TRIM-D) score, Change in EQ-5D-5L score, Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL], confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3)—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026