Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
NCT ID: NCT01662921
Last Updated: 2018-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2013-04-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NPH and insulin lispro
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
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Insulin LISPRO
Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
NPH and insulin glulisine
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.
NPH
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Insulin glulisine
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Interventions
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NPH
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Insulin LISPRO
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
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnant and 20-30 weeks gestation
* Diagnosed with gestational diabetes
* Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal \<90mg/dL and post prandial \< 120mg/dL
* Eat at least 2 meals per day
Exclusion Criteria
* Blood pressure \> 140/80 mmHg
* A1C equal to or greater than 6.5% at time of enrollment
* Pre-pregnancy BMI \> 40Kg/m squared
* Evidence of any fetal anomaly on any fetal ultrasound
* Currently using hypoglycemic agent
* Refusal to use insulin before meals
* Inability to understand instructions or to consent to participate
* Pregnant women with history of T1DM or T2DM
* Clinical judgment by investigator that patient is inappropriate for clinical trial or has a metabolic disorder that could interfere with results
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Sansum Diabetes Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kristin Castorino, DO
Role: PRINCIPAL_INVESTIGATOR
Sansum Diabetes Research Institute
Leonie Mattison, PhD
Role: STUDY_DIRECTOR
Sansum Diabetes Research Institute
Locations
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William Sansum Diabetes Center
Santa Barbara, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Web page for Sansum Diabetes Research Institute
Other Identifiers
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APIDRL06229
Identifier Type: -
Identifier Source: org_study_id
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