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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
Must not have
Chronic renal or hepatic insufficiency
Age < 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant, have diabetes (type 2 or gestational), and need insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have long-term kidney or liver problems.
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I am under 18 years old.
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I have Type 1 Diabetes.
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I am positive for HIV, Hepatitis B, or Hepatitis C.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal Hypoglycemia
Prolonged neonatal hypoglycemia
Secondary study objectives
5 Minute APGAR
Fetal anomolies
Gestational Age at delivery
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,568 Previous Clinical Trials
10,313,936 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
~42 spots leftby Jun 2025
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