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Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

Information source: William Sansum Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes During Pregnancy

Intervention: NPH (Drug); Insulin LISPRO (Drug); Insulin glulisine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: William Sansum Diabetes Center

Official(s) and/or principal investigator(s):
Kristin Castorino, DO, Principal Investigator, Affiliation: William Sansum Diabetes Center
Leonie Mattison, PhD, Study Director, Affiliation: William Sansum Diabetes Center

Summary

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.

Clinical Details

Official title: Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus

Secondary outcome:

Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge

Compare A1C at enrollment and weekly until delivery

Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Informed Consent to participate in clinical trial

- 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:

- Pregnant women <18 years old

- 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

Locations and Contacts

William Sansum Diabetes Center, Santa Barbara, California 93105, United States
Additional Information

Web page for Sansum Diabetes Research Institute

Related publications:

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, Jovanovič 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. Review.

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. Review. Erratum in: Diabetes Care. 2007 Dec;30(12):3154.

Arnolds S, Rave K, Hövelmann 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.

9. Manderson JG, Patterson CC, Hadden DR, Traub Al, Ennis C, McCance DR. Preprandial versus postprandial blood glucose monitoring in type 1 diabetic pregnancy: a randomized controlled clinical trial. Am J Obstet gynecol 189(2):507 512, 2003.Jovanovic L, Druzin M, Peterson CM. The effect of euglycemia on the outcome of pregnancy in insulin-dependent diabetics as compared to normal controls. Am J Med. 71:921-927, 1981

Starting date: April 2013
Last updated: May 18, 2015

Page last updated: August 23, 2015

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