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Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

NCT01662921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Diabetes During Pregnancy

Interventions

DRUG

NPH

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

DRUG

Insulin LISPRO

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

DRUG

Insulin glulisine

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • Kristin Castorino, DO · Sansum Diabetes Research Institute

  • Leonie Mattison, PhD · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-01-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662921 on ClinicalTrials.gov