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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613807
• Other study ID #: SDRI 08-01
• Secondary ID: F3Z-US-X031
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2022
• Source: Sansum Diabetes Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sansum Diabetes Research Institute	Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C	Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C.	During Pregnancy (at approximately 28 weeks gestation)
Secondary	Birthweight of Infant	Birthweight of infant born to mother with gestational diabetes using insulin	End of pregnancy