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