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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin LISPRO
* Drug: Insulin, Long-Acting and Insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mix 50/50<br>Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime. | Drug: Insulin LISPRO<br>* 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.<br>* Other names: Humalog® Mix50/50™;|
| Active Comparator: Usual insulin regimen<br>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 | Drug: Insulin, Long-Acting and Insulin<br>* 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.<br>* Other names: Humalog (r);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | 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. | During Pregnancy (at approximately 28 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birthweight of Infant | Birthweight of infant born to mother with gestational diabetes using insulin | End of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes mellitus, insulin analogues in pregnancy