Trial record 4 of 914 for:    Open Studies | "Insulin"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 3, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
7. 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; 118(9):662-664.
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
Study First Received: August 7, 2012
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sansum Diabetes Research Institute:
bolus treatment

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

ClinicalTrials.gov processed this record on August 28, 2014