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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-US-X031 | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mix 50/50 | Experimental | Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime. |
|
| Usual insulin regimen | Active Comparator | Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin LISPRO | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Birthweight of Infant | Birthweight of infant born to mother with gestational diabetes using insulin | End of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Castorino, DO | Sansum Diabetes Research Institute | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mix 50/50 | 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. |
| BG001 | Usual Insulin Regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | A1c percent | During Pregnancy (at approximately 28 weeks gestation) |
|
7 months
During pregnancy and postpartum period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mix 50/50 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal demise, placental abruption | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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Subjects in Humalog 50/50 Mix arm were limited to carbohydrates with meals. They were unable to bolus for carbohydrate-containing snacks.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristin Castorino | Sansum Diabetes Research Institute | 8056827640 | 256 | kcastorino@sansum.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2008 | Jan 24, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D049528 | Insulin, Long-Acting |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Insulin, Long-Acting and Insulin | Drug | 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. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Birthweight of Infant | Birthweight of infant born to mother with gestational diabetes using insulin | Posted | Mean | Standard Deviation | grams | End of pregnancy |
|
|
|
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Usual Insulin Regimen | 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. | 0 | 20 | 0 | 20 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |