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

Sansum Diabetes Research Institute17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes During Pregnancy

Interventions

NPHDRUG

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

Insulin LISPRODRUG

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

Insulin glulisineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

William Sansum Diabetes Center

Santa Barbara, California, United States

Outcomes

Primary Outcomes

show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus

compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro

Time frame: week 4 of insulin treatment

Secondary Outcomes

Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge

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.

Time frame: week 2 of insulin treatment

Compare A1C at enrollment and weekly until delivery

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.

Time frame: up to 36 weeks

Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms

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.

Time frame: up to 36 weeks

Data from ClinicalTrials.gov

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