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

Primary Purpose

Diabetes During Pregnancy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NPH
Insulin LISPRO
Insulin glulisine
Sponsored by
Sansum Diabetes Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes During Pregnancy focused on measuring bolus treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • William Sansum Diabetes Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NPH and insulin lispro

NPH and insulin glulisine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Compare A1C at enrollment and weekly until delivery
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.
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.

Full Information

First Posted
August 7, 2012
Last Updated
April 16, 2018
Sponsor
Sansum Diabetes Research Institute
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01662921
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 31, 2015 (Actual)
Study Completion Date
August 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sansum Diabetes Research Institute
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes During Pregnancy
Keywords
bolus treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPH and insulin lispro
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NPH and insulin glulisine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NPH
Other Intervention Name(s)
Humulin N, Novolin N
Intervention Description
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Other Intervention Name(s)
Humalog
Intervention Description
Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Other Intervention Name(s)
Apidra
Intervention Description
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Primary Outcome Measure Information:
Title
show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus
Description
compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro
Time Frame
week 4 of insulin treatment
Secondary Outcome Measure Information:
Title
Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge
Description
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.
Time Frame
week 2 of insulin treatment
Title
Compare A1C at enrollment and weekly until delivery
Description
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.
Time Frame
up to 36 weeks
Title
Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
Description
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.
Time Frame
up to 36 weeks
Other Pre-specified Outcome Measures:
Title
Compare incidence of birth weight >90th percentile
Time Frame
delivery
Title
Compare incidence of primary cesarean section
Time Frame
delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Castorino, DO
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonie Mattison, PhD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
William Sansum Diabetes Center
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States

12. IPD Sharing Statement

Citations:
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.
Results Reference
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PubMed Identifier
21148303
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.
Results Reference
background
PubMed Identifier
18463375
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.
Results Reference
background
PubMed Identifier
17596476
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. Erratum In: Diabetes Care. 2007 Dec;30(12):3154.
Results Reference
background
PubMed Identifier
20429049
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.
Results Reference
background
PubMed Identifier
14520226
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.
Results Reference
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Links:
URL
http://www.sansum.org
Description
Web page for Sansum Diabetes Research Institute

Learn more about this trial

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

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