← Back to Search

Insulin

Insulin Detemir vs NPH for Gestational Diabetes (DETERMINE Trial)

Phase 2

Recruiting

Led By Christina Han, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant women with pre-existing T2DM and GDM who require insulin to manage their blood sugars in pregnancy.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

DETERMINE Trial Summary

This trial will compare rates of neonatal hypoglycemia in mothers who use NPH insulin to those who use determir.

Who is the study for?

This trial is for pregnant women with Type 2 or gestational diabetes needing insulin. It's not for those under 18, with a planned early delivery, pre-pregnancy insulin use, type 1 diabetes, HIV/Hepatitis infections, fetal malformations, kidney/liver issues, or expecting multiples.Check my eligibility

What is being tested?

The DETERMINE study compares the effects of two types of insulin on newborns' blood sugar levels when their mothers have Type 2 or gestational diabetes: Insulin Detemir versus Insulin NPH.See study design

What are the potential side effects?

Possible side effects include low blood sugar levels in both mother and baby. Mothers may also experience typical insulin-related reactions like injection site reactions and allergic responses.

DETERMINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant, have diabetes (type 2 or gestational), and need insulin.

DETERMINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neonatal Hypoglycemia

Prolonged neonatal hypoglycemia

Secondary outcome measures

5 Minute APGAR

Fetal anomolies

Gestational Age at delivery

+14 more

DETERMINE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Insulin DetemirExperimental Treatment1 Intervention

Patients are to receive insulin detemir as long acting insulin to control blood sugars

Group II: Insulin NPHActive Control1 Intervention

Patients are to receive insulin NPH as long acting insulin to control blood sugars

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin Detemir

2008

Completed Phase 4

~1050

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,264,932 Total Patients Enrolled

Christina Han, MDPrincipal InvestigatorUniversity of California, Los Angeles

Michael Richley, MDStudy DirectorUniversity of California, Los Angeles

Media Library

Insulin Detemir (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05124457 — Phase 2

Gestational Diabetes Research Study Groups: Insulin Detemir, Insulin NPH

Gestational Diabetes Clinical Trial 2023: Insulin Detemir Highlights & Side Effects. Trial Name: NCT05124457 — Phase 2

Insulin Detemir (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05124457 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions are commonly helped by Insulin Detemir?

"Insulin Detemir can help manage type 1 diabetes mellitus, diabetes mellitus, and insulin-dependent patients."

Answered by AI

How many test subjects are in this experiment?

"Yes, the information on clinicaltrials.gov says that this trial is currently recruiting patients. The study was first posted on 2/1/2022 and was last updated on 4/25/2022. The clinical trial is admitting 336 patients across 1 locations."

Answered by AI

Are any places still available for people who want to participate in this research project?

"This clinical trial, which was first posted on February 1st 2022, is actively seeking patients. The most recent update was on April 25th 2022."

Answered by AI

Has the FDA cleared insulin detemir for therapeutic use?

"While Phase 2 trials offer less data supporting a medication's safety, insulin Detemir received a score of 2."

Answered by AI

To the best of your knowledge, are there other Insulin Detemir studies that have been conducted?

"There are currently 82 clinical trials underway that focus on Insulin Detemir. Out of these, 14 are in Phase 3. Additionally, there are 265 different locations where at least one trial is taking place."

Answered by AI

Could you state the main goals of this clinical trial?

"The primary outcome being monitored in this trial is Neonatal Hypoglycemia, which will be observed over the course of 24 hours after birth but before discharge. Additionally, weight, APGAR score, and need for dextrose infusion will be secondary outcomes neonates."

Answered by AI