Gestational Diabetes Mellitus
Conditions
Keywords
gestational diabetes mellitus, insulin analogues in pregnancy
Brief 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.
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.
Interventions
DRUGInsulin 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.
DRUGInsulin, 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.
Sponsors
Eli Lilly and Company
Sansum Diabetes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birthweight of Infant | End of pregnancy | Birthweight of infant born to mother with gestational diabetes using insulin |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Usual Insulin Regimen | Mix 50/50 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Continuous | 33.6 years STANDARD_DEVIATION 4.5 | 29.6 years STANDARD_DEVIATION 4.8 | 31.6 years STANDARD_DEVIATION 4.65 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 |
Outcome results
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.
Time frame: During Pregnancy (at approximately 28 weeks gestation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mix 50/50 | Hemoglobin A1C | 5.5 A1c percent | Standard Deviation 0.3 |
| Usual Insulin Regimen | Hemoglobin A1C | 5.6 A1c percent | Standard Deviation 0.3 |
Secondary
Birthweight of Infant
Birthweight of infant born to mother with gestational diabetes using insulin
Time frame: End of pregnancy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mix 50/50 | Birthweight of Infant | 3178 grams | Standard Deviation 519 |
| Usual Insulin Regimen | Birthweight of Infant | 3375 grams | Standard Deviation 419 |