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

Information source: William Sansum Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gestational Diabetes Mellitus

Intervention: Insulin LISPRO (Drug); Insulin, Long-Acting and Insulin LISPRO (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: William Sansum Diabetes Center

Official(s) and/or principal investigator(s):
Lois Jovanovic, MD, Principal Investigator, Affiliation: William Sansum Diabetes Center

Summary

Humalog Mix50/50TM administered as 3 injections daily is equivalent to Humalog plus Humulin N insulin administered as 6 separate injections daily in terms of glucose control, but may have some advantages due to increased ease of use.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Fasting self-monitored blood glucose measurements

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.

Eligibility

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Female.

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.

Locations and Contacts

Additional Information

Starting date: October 2008
Last updated: June 6, 2012

Page last updated: August 23, 2015

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