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

Sansum Diabetes Research Institute

Status and phase: Completed; Phase 4

Conditions: Gestational Diabetes Mellitus

Treatments: Drug: Insulin, Long-Acting and Insulin; Drug: Insulin LISPRO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01613807

SDRI 08-01

F3Z-US-X031 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mix 50/50

Experimental group

Description:

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

Treatment:

Drug: Insulin LISPRO

Usual insulin regimen

Active Comparator group

Description:

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

Treatment:

Drug: Insulin, Long-Acting and Insulin