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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.
To date, only two rapid-acting insulin analogs have been shown to be safe and effective for the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.
The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin glulisine may be the best rapid-acting analog for the treatment of post-prandial hyperglycemia. We believe that insulin glulisine should be evaluated in women with gestational diabetes for its potential efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPH and insulin lispro | Active Comparator | Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average. |
|
| NPH and insulin glulisine | Active Comparator | Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH | Drug | Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age |
|
| Measure | Description | Time Frame |
|---|---|---|
| show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus | compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro | week 4 of insulin treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge | patients will come to the study site under fasting conditions and eat a standardized meal in the morning post administration of insulin NPH and their randomized bolus insulin. | week 2 of insulin treatment |
| Compare A1C at enrollment and weekly until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Compare incidence of birth weight >90th percentile | delivery | |
| Compare incidence of primary cesarean section | delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Castorino, DO | Sansum Diabetes Research Institute | Principal Investigator |
| Leonie Mattison, PhD | Sansum Diabetes Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Sansum Diabetes Center | Santa Barbara | California | 93105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Centers for Disease Control and Prevention: National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. | ||
| 21148303 | Background | Castorino K, Jovanovic L. Pregnancy and diabetes management: advances and controversies. Clin Chem. 2011 Feb;57(2):221-30. doi: 10.1373/clinchem.2010.155382. Epub 2010 Dec 9. | |
| 18463375 |
| Label | URL |
|---|---|
| Web page for Sansum Diabetes Research Institute | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 7, 2022 | |
| Reset | Jun 30, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 7, 2022 | Jun 30, 2022 |
| 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 |
|---|---|
| D000068880 | Isophane Insulin, Human |
| D061268 | Insulin Lispro |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D007336 | Insulin, Isophane |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
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|
| Insulin LISPRO | Drug | Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days |
|
|
| Insulin glulisine | Drug | Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days |
|
|
A1C is measured weekly at each pregnancy visit up to 26 visits. Subjects are enrolled at 20-32 weeks gestation and have weekly visits to obtain A1C through delivery, and again at the 6-week postpartum visit. |
| up to 36 weeks |
| Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms | Hypoglycemic episodes since the last visit will be reported at each pregnancy visit, usually weekly, from enrollment at 10-30 weeks gestation through delivery and at the 6-week postpartum visit if continuing to take insulin. | up to 36 weeks |
| Background |
| HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943. |
| 17596476 | Background | Jovanovic L, Pettitt DJ. Treatment with insulin and its analogs in pregnancies complicated by diabetes. Diabetes Care. 2007 Jul;30 Suppl 2:S220-4. doi: 10.2337/dc07-s220. No abstract available. |
| 20429049 | Background | Arnolds S, Rave K, Hovelmann U, Fischer A, Sert-Langeron C, Heise T. Insulin glulisine has a faster onset of action compared with insulin aspart in healthy volunteers. Exp Clin Endocrinol Diabetes. 2010 Oct;118(9):662-4. doi: 10.1055/s-0030-1252067. Epub 2010 Apr 28. |
| 14520226 | Background | Manderson JG, Patterson CC, Hadden DR, Traub AI, Ennis C, McCance DR. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet Gynecol. 2003 Aug;189(2):507-12. doi: 10.1067/s0002-9378(03)00497-6. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061386 | Insulin, Regular, Human |
| D007328 | Insulin |
| D011384 | Proinsulin |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |