DETERMINE: Detemir vs NPH (DETERMINE)
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ClinicalTrials.gov Identifier: NCT05124457 |
Recruitment Status :
Recruiting
First Posted : November 18, 2021
Last Update Posted : September 26, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Diabetes Diabetes Mellitus, Type 2 | Drug: Insulin Detemir Drug: Insulin NPH | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 336 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomization to receive either insulin NPH or insulin detemir |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study |
Actual Study Start Date : | February 1, 2022 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | June 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Insulin Detemir
Patients are to receive insulin detemir as long acting insulin to control blood sugars
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Drug: Insulin Detemir
Patients are to receive insulin detemir |
Active Comparator: Insulin NPH
Patients are to receive insulin NPH as long acting insulin to control blood sugars
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Drug: Insulin NPH
Patients are to receive insulin NPH |
- Neonatal Hypoglycemia [ Time Frame: Within the first 24 hours of life ]Rate (%) of neonatal hypoglycemia
- Prolonged neonatal hypoglycemia [ Time Frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge ]Rate (%) of prolonged neonatal hypoglycemia
- Neonatal Gastrin Level [ Time Frame: At birth ]Sample form cord blood
- Neonatal C-Peptide Level [ Time Frame: At birth ]Sample from cord blood
- Neonatal insulin level [ Time Frame: At birth ]Sample from cord blood
- Neonatal leptin level [ Time Frame: At birth ]Sample from cord blood
- Rates of pregnancy induced hypertension [ Time Frame: 1 year ]Maternal rates of preeclampsia, eclampsia, or gestational hypertension
- Mode of delivery [ Time Frame: At delivery ]Spontaneous vaginal, operative vaginal, cesarean
- Gestational Age at delivery [ Time Frame: At delivery ]Gestational Age at delivery
- Maternal glycemic control [ Time Frame: 1 year ]Rate (%) of in range maternal blood glucose control in antepartum period
- Total daily insulin [ Time Frame: 1 year ]Total daily insulin dose in patient
- Fetal anomolies [ Time Frame: At birth ]Rate (%) of fetal anomolies
- Macrosomia [ Time Frame: At birth ]Rate (%) of macrosomia
- Polyhydramnios [ Time Frame: At birth ]Rate (%) of polyhydramnios
- Neonatal weight [ Time Frame: At birth ]Neonatal weight
- Need for supplemental oxygen [ Time Frame: 1 year ]Rate of supplemental oxygen use (%) in neonate
- Need for dextrose infusion in neonate [ Time Frame: 1 year ]Rate of dextrose infusion use (%) in neonate
- Rates of respiratory distress syndrome [ Time Frame: 1 year ]Rate of RDS (%) in neonate
- 5 Minute APGAR [ Time Frame: At birth ]5 Minute APGAR
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Exclusion Criteria:
- Multiple Gestation
- Type 1 Diabetes mellatus
- Age < 18
- Known or suspected hypersensitivity to NPH or insulin detemir
- Known fetal major malformations
- Chronic renal or hepatic insufficiency
- Known to be HIV, Hepatitis B, or Hepatitis C positive
- Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
- Insulin dependent before conception
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124457
Contact: Michael Richley, MD | 310-794-7274 | mrichley@mednet.ucla.edu | |
Contact: Christina Han, MD | 310-794-7274 | cshan@mednet.ucla.edu |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90069 | |
Contact: Christina S Han, MD cshan@mednet.ucla.edu | |
Contact: Michael A Richley, MD mrichley@mednet.ucla.edu |
Principal Investigator: | Christina Han, MD | University of California, Los Angeles | |
Study Director: | Michael Richley, MD | University of California, Los Angeles |
Publications:
Responsible Party: | Christina S. Han, Maternal-Fetal Medicine Division Director, University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT05124457 |
Other Study ID Numbers: |
DETERMINE |
First Posted: | November 18, 2021 Key Record Dates |
Last Update Posted: | September 26, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Diabetes, Gestational Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Insulin Insulin, Globin Zinc Insulin Detemir Isophane Insulin, Human Insulin, Isophane Isophane insulin, beef Hypoglycemic Agents Physiological Effects of Drugs |