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Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes

NCT01613807 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-08

Study results available
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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.

Conditions

  • Gestational Diabetes Mellitus

Interventions

DRUG

Insulin LISPRO

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.

DRUG

Insulin, Long-Acting and Insulin

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.

Sponsors & Collaborators

Principal Investigators

  • Kristin Castorino, DO · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-06-30
Completion
2010-10-31

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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 NCT01613807 on ClinicalTrials.gov