CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Insulin LISPRO +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01613807
NCT01613807Phase 4Completed
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Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes

Sansum Diabetes Research Institute·interventional·Posted Jun 7, 2012·Updated Jun 8, 2022

In Brief

A Phase 4 clinical trial evaluating Insulin LISPRO and Insulin, Long-Acting and Insulin for Gestational Diabetes Mellitus. Completed, enrolled 40 participants.

Detailed Summary

Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGestational Diabetes Mellitus
Countries--
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2012
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.1 years ago

Interventions

Insulin LISPROdrug

Humalog® Mix50/50™ \[50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)\], three times daily at mealtime. Dose determined by blood glucose history.

Insulin, Long-Acting and Insulindrug

Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.