CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
NPH +2 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/NCT01662921
NCT01662921Phase 2Completed
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Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.

Sansum Diabetes Research Institute·interventional·Posted Aug 13, 2012·Updated Apr 18, 2018

In Brief

A Phase 2 clinical trial evaluating NPH, Insulin LISPRO, and 1 other intervention for Diabetes During Pregnancy. Completed, enrolled 17 participants across 1 site.

Detailed Summary

We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes During Pregnancy
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2012
Enrollment StartApr 1, 2013
Primary CompletionJan 31, 2015
Study CompletionAug 31, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

NPHdrug

Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age

Insulin LISPROdrug

Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Insulin glulisinedrug

Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days