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

This study is currently recruiting participants.
Verified May 2013 by Sansum Diabetes Research Institute
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier:
NCT01662921
First received: August 7, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes During Pregnancy
 Drug: NPH
Drug: Insulin LISPRO
Drug: Insulin glulisine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sansum Diabetes Research Institute:

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 [ Time Frame: week 4 of insulin treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2 of insulin treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 36 weeks ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Compare incidence of birth weight >90th percentile [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Compare incidence of primary cesarean section [ Time Frame: delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: April 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Drug: NPH
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Other Name: Humulin N, Novolin N
Drug: 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
Other Name: Humalog
Active Comparator: 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.
 Drug: NPH
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
Other Name: Humulin N, Novolin N
Drug: 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 Name: Apidra

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662921

Contacts
Contact: Lois Jovanovic, MD 805-682-7638 ljovanovic@sansum.org
Contact: Kristin Castorino, DO 805-682-7638 kcastorino@sansum.org

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Principal Investigator: Lois Jovanovic, MD            
Sub-Investigator: Kristin Castorino, DO            
Sponsors and Collaborators
Sansum Diabetes Research Institute
Sanofi
Investigators
Principal Investigator: Lois Jovanovic, MD Sansum Diabetes Research Institute
Study Director: Kristin Castorino, DO Sansum Diabetes Research Institute
  More Information

Additional Information:
Web page for Sansum Diabetes Research Institute  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01662921     History of Changes
Other Study ID Numbers: APIDRL06229
Study First Received: August 7, 2012
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sansum Diabetes Research Institute:
bolus treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin LISPRO
 Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013