Repurposing colchicine for reduction of residual inflammatory risk in type 1 diabetes (REC1TE): a randomized, double-blind, placebo-controlled, investigator-initiated trial

Conditions

Type 1 diabetes

Brief summary

Estimated treatment difference in high-sensitivity C-reactive protein (mg/l) for colchicine as compared with placebo after 26 weeks of treatment

Detailed description

High-sensitivity C-reactive protein (mg/l) (measured at week 30), Glycated haemoglobin (mmol/mol; %-point), Time spent in target glycemia (3.9–10 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 1 (10–13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 2 (> 13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 1 (3.0–3.8 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 2 (< 3.0 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Insulin dosage, long-acting (units/day), Insulin dosage, short-acting (units/day), Body weight (kg), Waist:hip ratio, Low-density lipoprotein cholesterol (mmol/l), Interleukin-6 (pg/ml), Tumour necrosis factor alpha (pg/ml), Serious adverse events (SAE), Events of severe hypoglycemia, Events of diabetic ketoacidosis

Related papers

No related papers found yet.

Interventions

DRUGColrefuz

DRUGtabletter

DRUGPlacebo for colchicine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Estimated treatment difference in high-sensitivity C-reactive protein (mg/l) for colchicine as compared with placebo after 26 weeks of treatment	—

Secondary

Measure	Time frame
High-sensitivity C-reactive protein (mg/l) (measured at week 30), Glycated haemoglobin (mmol/mol; %-point), Time spent in target glycemia (3.9–10 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 1 (10–13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 2 (> 13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 1 (3.0–3.8 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 2 (< 3.0 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Insulin dosage, long-acting (units/day), Insulin dosage, short-acting (units/day), Body weight (kg), Waist:hip ratio, Low-density lipoprotein cholesterol (mmol/l), Interleukin-6 (pg/ml), Tumour necrosis factor alpha (pg/ml), Serious adverse events (SAE), Events of severe hypoglycemia, Events of diabetic ketoacidosis	—

Measure

Time frame

High-sensitivity C-reactive protein (mg/l) (measured at week 30), Glycated haemoglobin (mmol/mol; %-point), Time spent in target glycemia (3.9–10 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 1 (10–13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hyperglycaemia level 2 (> 13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 1 (3.0–3.8 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Time spent in hypoglycaemia level 2 (< 3.0 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring, Insulin dosage, long-acting (units/day), Insulin dosage, short-acting (units/day), Body weight (kg), Waist:hip ratio, Low-density lipoprotein cholesterol (mmol/l), Interleukin-6 (pg/ml), Tumour necrosis factor alpha (pg/ml), Serious adverse events (SAE), Events of severe hypoglycemia, Events of diabetic ketoacidosis

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Countries

Denmark

Outcome results

None listed