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

April 16, 2018 updated by: Sansum Diabetes Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • William Sansum Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Apidra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 4 of insulin treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 2 of insulin treatment
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.
up to 36 weeks
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.
up to 36 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Compare incidence of birth weight >90th percentile
Time Frame: delivery
delivery
Compare incidence of primary cesarean section
Time Frame: delivery
delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sansum Diabetes Research Institute

Collaborators

Sanofi

Investigators

  • Study Director: Leonie Mattison, PhD, Sansum Diabetes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

January 31, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIDRL06229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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