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NCT02006342: GT-COG
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study
NA trial testing Insulin Glargine in Diabetic Ketoacidosis in 40 participants. Completed in 1 April 2013.
1 April 2013
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2012 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Insulin Glargine (INSULIN GLARGINE) — full drug profile →
- Regular Insulin — full drug profile →
Conditions studied
- Diabetic Ketoacidosis — all drugs for Diabetic Ketoacidosis →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
18 and older, any sex, with Diabetic Ketoacidosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to Anion Gap Closure
Time frame: Participants monitored from hospital admission to discharge, an average of 4 days
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, eti
Sponsor's own description
To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Subcutaneous rapid-acting insulin analogues for diabetic ketoacidosis.
Andrade-Castellanos CA, Colunga-Lozano LE, Delgado-Figueroa N, Gonzalez-Padilla DA. · · 2016 · cited 36× · PMID 26798030 · DOI 10.1002/14651858.cd011281.pub2
Verify or expand the search:
- PubMed search for NCT02006342
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Insulin Glargine
Trials testing the same drug.
- NCT06370715 — A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India · Phase 4 · completed
- NCT06178874 — Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia · NA · completed
- NCT05803421 — A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and O · Phase 3 · completed
- NCT05702073 — To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With · Phase 3 · completed
- NCT05699408 — To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequate · Phase 3 · completed
Other recruiting trials for Diabetic Ketoacidosis
Currently open trials in the same condition.
- NCT07167693 — Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes · Phase 1, PHASE2 · recruiting
- NCT07127406 — Postoperative Euglycemic Ketoacidosis Frequency in Sodium-Glucose Cotransporter-2 Inhibitor Users · active not recruiting
- NCT06955416 — REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis · Phase 2, PHASE3 · recruiting
- NCT07193069 — Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning · recruiting
Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
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- NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
- NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
- NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02006342 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 10 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02006342.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing