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

Phase 4

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Drug: Insulin LISPRO; Drug: Insulin, Long-Acting and Insulin

• Registration Number: NCT01613807
• Lead Sponsor: Sansum Diabetes Research Institute

Brief 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.

Detailed Description

Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.

Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2010-06
• Study Completion: 2010-10
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Results First Submitted: 2015-05-18
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-07
• Last Update Submitted: 2022-06-07
• Results First Posted: 2022-06-08
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• <18 years old or over 45 years old
• urine dipstick >2+ protein
• blood pressure >140/80 mmHg
• hematocrit <30%
• refusal to take insulin
• inability to understand instructions or to consent to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mix 50/50	Insulin LISPRO	Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.
Usual insulin regimen	Insulin, Long-Acting and Insulin	Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	During Pregnancy (at approximately 28 weeks gestation)	Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C.

Secondary Outcome Measures

Name	Time	Method
Birthweight of Infant	End of pregnancy	Birthweight of infant born to mother with gestational diabetes using insulin