A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination with Insulin Aspart, in Adults with Type 1 Diabetes

Conditions

Type 1 Diabetes

Brief summary

Change in HbA1c From baseline week 0 (V6) to week 26 (V32). Unit: %-point

Detailed description

Change in time in range 3.9– 10.0 mmol/L (70–180 mg/dL). Using CGM system, Dexcom G7, Time spent <3.0 mmol/L (54 mg/dL). Using CGM system, Dexcom G7, Change in time spent >10.0 mmol/L (180 mg/dL). Using CGM system, Dexcom G7, Number of severe hypoglycaemic episodes (level 3), Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter), 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), Number of CGM-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]). Using CGM system, Dexcom G7, Mean total weekly insulin dose, Change in body weight, Change in ITSQ total score, Change in ADAQ total score

Related papers

No related papers found yet.

Interventions

DRUGAwiqli 700 units/mL solution for injection in pre-filled pen

DRUGLantus SoloStar 100 units/ml solution for injection in a pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in HbA1c From baseline week 0 (V6) to week 26 (V32). Unit: %-point	—

Secondary

Measure	Time frame
Change in time in range 3.9– 10.0 mmol/L (70–180 mg/dL). Using CGM system, Dexcom G7, Time spent <3.0 mmol/L (54 mg/dL). Using CGM system, Dexcom G7, Change in time spent >10.0 mmol/L (180 mg/dL). Using CGM system, Dexcom G7, Number of severe hypoglycaemic episodes (level 3), Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter), 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), Number of CGM-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]). Using CGM system, Dexcom G7, Mean total weekly insulin dose, Change in body weight, Change in ITSQ total score, Change in ADAQ total score	—

Measure

Time frame

Change in time in range 3.9– 10.0 mmol/L (70–180 mg/dL). Using CGM system, Dexcom G7, Time spent <3.0 mmol/L (54 mg/dL). Using CGM system, Dexcom G7, Change in time spent >10.0 mmol/L (180 mg/dL). Using CGM system, Dexcom G7, Number of severe hypoglycaemic episodes (level 3), Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL], confirmed by BG meter), 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), Number of CGM-based clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L [54 mg/dL]). Using CGM system, Dexcom G7, Mean total weekly insulin dose, Change in body weight, Change in ITSQ total score, Change in ADAQ total score

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Countries

Germany, Poland, Romania, Slovakia

Outcome results

None listed