Clinical trial NCT01662921: Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes During Pregnancy
Keywords: bolus treatment
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-08-13
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
timeFrame: week 4 of insulin treatment
Secondary outcomes:
measure: Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge
timeFrame: week 2 of insulin treatment
measure: Compare A1C at enrollment and weekly until delivery
timeFrame: up to 36 weeks
measure: Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
timeFrame: up to 36 weeks
Other outcomes:
measure: Compare incidence of birth weight >90th percentile
timeFrame: delivery
measure: Compare incidence of primary cesarean section
timeFrame: delivery
Locations:
city: Santa Barbara
country: United States
facility: William Sansum Diabetes Center
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Kristin Castorino, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Leonie Mattison, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.