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

Sansum Diabetes Research Institute

Status and phase: Completed; Phase 2

Conditions: Diabetes During Pregnancy

Treatments: Drug: Insulin LISPRO; Drug: NPH; Drug: Insulin glulisine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01662921

APIDRL06229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

NPH and insulin lispro

Active Comparator group

Description:

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.

Treatment:

Drug: NPH

Drug: Insulin LISPRO

NPH and insulin glulisine

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin glulisine

Drug: NPH