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
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