NCT01662921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

August 7, 2012

Last Update Submit

April 16, 2018

Conditions

Diabetes During Pregnancy

Keywords

bolus treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

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

    week 2 of insulin treatment

  • Compare A1C at enrollment and weekly until delivery

    up to 36 weeks

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

    up to 36 weeks

Other Outcomes (2)

  • Compare incidence of birth weight >90th percentile

    delivery

  • Compare incidence of primary cesarean section

    delivery

Study Arms (2)

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.

Drug: NPHDrug: Insulin LISPRO

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.

Drug: NPHDrug: Insulin glulisine

Interventions

NPHDRUG

Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age

Also known as: Humulin N, Novolin N
NPH and insulin glulisineNPH and insulin lispro
Insulin LISPRODRUG

Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Also known as: Humalog
NPH and insulin lispro
Insulin glulisineDRUG

Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Also known as: Apidra
NPH and insulin glulisine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Related Publications (6)

  • 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.

    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.

    PMID: 21148303BACKGROUND

  • 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.

    PMID: 18463375BACKGROUND

  • 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.

    PMID: 17596476BACKGROUND

  • 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.

    PMID: 20429049BACKGROUND

  • 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.

    PMID: 14520226BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Isophane Insulin, HumanInsulin Lisproinsulin glulisine

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, IsophaneInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsInsulin, Regular, HumanInsulinProinsulinPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Kristin Castorino, DO

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

  • Leonie Mattison, PhD

    Sansum Diabetes Research Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 13, 2012

Study Start

April 1, 2013

Primary Completion

January 31, 2015

Study Completion

August 31, 2015

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

US(1)