Phase 4 N=40 Randomized Treatment

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

Gestational Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01613807 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jun 2022

Primary outcome: Primary: Hemoglobin A1C — 5.5; 5.6 A1c percent

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Insulin LISPRO (Drug); Insulin, Long-Acting and Insulin (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Sansum Diabetes Research Institute
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin A1C	5.5; 5.6	—
SECONDARY Birthweight of Infant	3178; 3375	—

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.

Eligibility Criteria

Inclusion Criteria

Pregnant and at least 13 weeks gestation
Diagnosed with gestational diabetes mellitus
Failed diet therapy

Exclusion Criteria

2+ protein
blood pressure >140/80 mmHg
hematocrit <30%
refusal to take insulin
inability to understand instructions or to consent to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01613807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.