NCT01662921

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sansum Diabetes Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes During Pregnancy

Interventions

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

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-31
• Completion: 2015-08-31
• First posted: 2012-08-13
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States