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

NCT ID: NCT01613807

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-10-31

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mix 50/50

Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.

Group Type: EXPERIMENTAL

Insulin LISPRO

Intervention Type: DRUG

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.

Usual insulin regimen

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

Group Type: ACTIVE_COMPARATOR

Insulin, Long-Acting and Insulin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Humalog® Mix50/50™; Humalin N(r); Humalog (r)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kristin Castorino, DO

Research Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Castorino, DO

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

F3Z-US-X031

Identifier Type: OTHER

Identifier Source: secondary_id

SDRI 08-01

Identifier Type: -

Identifier Source: org_study_id