Trial Outcomes & Findings for Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes (NCT NCT01613807)

NCT ID: NCT01613807

Last Updated: 2022-06-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: During Pregnancy (at approximately 28 weeks gestation)
• Results posted on: 2022-06-08

Participant Flow

Participant milestones

Measure	Mix 50/50 Premixed "Mix 50/50" at mealtime, three times per day Humalog® Mix50/50™ \[50% insulin lispro protamine suspension mixed with 50% insulin lispro injection, (rDNA origin)\], given subcutaneously three times daily at mealtime, for a maximum of THREE total insulin injections per day. Dose determined by blood glucose history.	Control Group: Usual Insulin Regmien Multiple daily injections: 3 injections of Humalog(r) daily with meals; AND 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime Long-Acting and Rapid-acting insulin administered as SIX separate injections. Long-acting NPH insulin was given three times daily on rising, mid-afternoon, and before bed, and insulin lispro was administered three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mix 50/50 n=20 Participants 3 doses of Mix 50/50 at mealtime 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.	Usual Insulin Regimen n=20 Participants 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime Insulin, Long-Acting and Insulin LISPRO : 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.6 years STANDARD_DEVIATION 4.8 • n=5 Participants	33.6 years STANDARD_DEVIATION 4.5 • n=7 Participants	31.6 years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: During Pregnancy (at approximately 28 weeks gestation)

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.

Outcome measures

Measure	Mix 50/50 n=20 Participants 3 doses of Mix 50/50 at mealtime 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.	Usual Insulin Regimen n=20 Participants 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime Insulin, Long-Acting and Insulin LISPRO : 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.
Hemoglobin A1C	5.5 A1c percent Standard Deviation 0.3	5.6 A1c percent Standard Deviation 0.3

SECONDARY outcome

Timeframe: End of pregnancy

Birthweight of infant born to mother with gestational diabetes using insulin

Outcome measures

Measure	Mix 50/50 n=20 Participants 3 doses of Mix 50/50 at mealtime 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.	Usual Insulin Regimen n=20 Participants 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime Insulin, Long-Acting and Insulin LISPRO : 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.
Birthweight of Infant	3178 grams Standard Deviation 519	3375 grams Standard Deviation 419

Adverse Events

Mix 50/50

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Insulin Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mix 50/50 n=20 participants at risk 3 doses of Mix 50/50 at mealtime 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.	Usual Insulin Regimen n=20 participants at risk 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime Insulin, Long-Acting and Insulin LISPRO : 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.
Pregnancy, puerperium and perinatal conditions Fetal demise, placental abruption	5.0% 1/20 • Number of events 1 • 7 months During pregnancy and postpartum period	0.00% 0/20 • 7 months During pregnancy and postpartum period

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kristin Castorino

Sansum Diabetes Research Institute

Phone: 8056827640

Email: kcastorino@sansum.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60