Effectiveness and Safety of Early Insulin Glargine Administration in Combination with Continuous Intravenous Insulin Infusion in the Management of Diabetic Ketoacidosis: A Prospective Randomized Controlled Trial

Effectiveness and Safety of Early Insulin Glargine Administration in Combination 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

TCTR20200710006

Enrollment

Registered

2020-07-10

Start date

2020-05-01

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

Diabetic ketoacidosis Adult Basal insulin Diabetic ketoacidosis Hypoglycemia Hypokalemia Rebound hyperglycemia Type 2 diabetes mellitus

Interventions

Experimental Drug,No Intervention Drug

Insulin glargine,Standard treatment of DKA

Insulin glargine 0.3 unit/kg (adjusted dose to 0.15 u/kg in patient with CrCl &lt

30 ml/min) add on standard treatment of DKA (ADA guideline 2009),standard treatment of DKA (ADA guideline 2009)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Glargine allergy Euglycemic DKA Hemodynamic instability (need vasopressor to maintain hemodynamic status) Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Time to resolution of DKA When complete criteria of DKA resolution Time to resolution of DKA in medical record	—

Secondary

Measure	Time 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	—

Countries

Thailand

Contacts

Public ContactKitti Thammakosol

Ramathibodi hospital, Mahidol university

Jkkitti.tham@gmail.com0816498718

Outcome results

None listed

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