Overview

This trial is active, not recruiting.

Condition diabetes during pregnancy
Treatments nph, insulin lispro, insulin glulisine
Phase phase 2
Sponsor William Sansum Diabetes Center
Collaborator Sanofi
Start date April 2013
End date October 2015
Trial size 74 participants
Trial identifier NCT01662921, APIDRL06229

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
nph Humulin N, Novolin N
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
insulin lispro Humalog
Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
(Active Comparator)
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.
nph Humulin N, Novolin N
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
insulin glulisine Apidra
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days

Primary Outcomes

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

Secondary Outcomes

Measure
Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge
time frame: week 2 of insulin treatment
Compare A1C at enrollment and weekly until delivery
time frame: up to 36 weeks
Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms
time frame: up to 36 weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Kristin Castorino, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by William Sansum Diabetes Center.