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Comparison · NCT02006342-0bd7ac77

Insulin Glargine Plus Regular Insulin vs Control - Regular Insulin: Number of Participants Who Developed Hypoglycemia

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Insulin Glargine Plus Regular Insulin vs Control - Regular Insulin: Number of Participants Who Developed Hypoglycemia. Trial comparisons, record NCT02006342-0bd7ac77. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02006342-0bd7ac77

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.10.02790.301wilson
Risk in group 20.150.05240.36wilson
Risk difference, group 1 minus group 2-0.05-0.2720.173newcombe hybrid score
Risk ratio, group 1 over group 20.6670.1243.57log
Odds ratio, group 1 over group 20.630.09344.24log
Number needed to treat, for one fewer participant with the outcome on Insulin Glargine Plus Regular Insulin than on Control - Regular Insulin20from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: control.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Insulin Glargine Plus Regular Insulin
Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin
220OG000
Group 2Control - Regular InsulinPatient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin320OG001

Outcome

Type
SECONDARY
Title
Number of Participants Who Developed Hypoglycemia
Description
To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.~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.
Time frame
Participants monitored during the 24 hours after anion gap closure
Population
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).

Source ClinicalTrials.gov

Trial

Title
Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis
NCT number
NCT02006342
Phases
NA
Conditions
Diabetic Ketoacidosis
Interventions
Insulin Glargine, Regular Insulin
Lead sponsor
The University of Texas Health Science Center, Houston
Results first posted
2017-05-16

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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