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

August 7, 2012
December 3, 2013
April 2013
October 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01662921 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 at each pregnancy visit, usually weekly, from enrollment at 10-30 weeks gestation 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.
  • 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 ]
Same as current
 
Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes During Pregnancy
  • 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
  • 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
  • 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.
    Interventions:
    • Drug: NPH
    • Drug: Insulin LISPRO
  • 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.
    Interventions:
    • Drug: NPH
    • Drug: Insulin glulisine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
October 2017
October 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Lois Jovanovic, MD 805-682-7638 ljovanovic@sansum.org
Contact: Kristin Castorino, DO 805-682-7638 kcastorino@sansum.org
United States
 
NCT01662921
APIDRL06229
No
Sansum Diabetes Research Institute
Sansum Diabetes Research Institute
Sanofi
Principal Investigator: Lois Jovanovic, MD Sansum Diabetes Research Institute
Study Director: Kristin Castorino, DO Sansum Diabetes Research Institute
Sansum Diabetes Research Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP