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Early insulin degludec with continuous intravenous insulin infusion in the management of diabetic ketoacidosis: A randomized controlled trial

Early insulin degludec with continuous intravenous insulin infusion in the management of diabetic ketoacidosis: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230408002
Enrollment
80
Registered
2023-04-08
Start date
2023-03-20
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adults (18 or more than 18 years old) with Diabetic ketoacidosis basal insulin diabetic ketoacidosis hypoglycemia hypokalemia long-acting insulin rebound hyperglycemia type 2 diabetes mellitus

Interventions

Insulin degludec 0.3 unit/kg (adjusted dose to 0.15 u/kg in patients with CrCl less than 30 ml/min) add on standard treatment of DKA (ADA guideline 2009),Standard treatment of DKA (ADA guideline 2009
Experimental Drug,No Intervention No treatment
Degludec,Standard treatment of DKA

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand (Funding for project number RF66046).
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adult patients who age at least 18 years old and were diagnosed with DKA

Exclusion criteria

Exclusion criteria: Insulin allergy Euglycemic DKA (Plasma glucose levels lower than 250 mg/dL,) Hemodynamic instability (need vasopressor to maintain hemodynamic status) Pregnant or breastfeeding women Receive a SC treatment regimen for mild DKA

Design outcomes

Primary

MeasureTime frame
Time to resolution of DKA When meet the complete criteria of DKA resolution Time to resolution of DKA in medical record

Secondary

MeasureTime frame
Rebound hyperglycemia at least 12 hours after discontinuation of IV insulin infusion Routinely checked capillary blood glucose (at least 4 times per day: before meal and bedtime) after discontinuation of IV insulin infusion,Hypoglycemia During receive intravenous insulin infusion and 24 hours after DKA resolution Capillary blood glucose below than 70 mg/dL,Hypokalemia During receive intravenous insulin infusion and 24 hours after DKA resolution Serum potassium below than 3.5 mEq/L

Countries

Thailand

Contacts

Public ContactKitti Thammakosol

Faculty of Medicine Ramathibodi hospital

Jkkitti.tham@gmail.com0816498718

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026