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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Sansum Diabetes Research Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662921
First Posted: August 13, 2012
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Sansum Diabetes Research Institute
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Compare incidence of primary cesarean section [ Time Frame: delivery ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662921


Locations
United States, California
William Sansum Diabetes Center
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Sansum Diabetes Research Institute
Sanofi
Investigators
Principal Investigator: Kristin Castorino, DO Sansum Diabetes Research Institute
Study Director: Leonie Mattison, PhD Sansum Diabetes Research Institute
  More Information

Additional Information:
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.
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

Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01662921     History of Changes
Other Study ID Numbers: APIDRL06229
First Submitted: August 7, 2012
First Posted: August 13, 2012
Last Update Posted: May 20, 2015
Last Verified: May 2015

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, Globin Zinc
Insulin glulisine
Insulin
Insulin Lispro
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs