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Completed

NCT Number: NCT01662921

Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for 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.

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Key information

Conditions

Diabetes During Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NPH

Drug

Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age

Other names: Humulin N, Novolin N

Insulin Lispro

Drug

Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Other names: Humalog

insulin glulisine

Drug

Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Other names: Apidra

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. Compare incidence of birth weight >90th percentile

    Time frame: delivery

  2. Compare incidence of primary cesarean section

    Time frame: delivery

Sponsors and collaborators

Lead sponsor

Sansum Diabetes Research Institute

Other

Collaborators

  • Sanofi

Registry information

Official study title

Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2012
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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