Gestational DiabetesPhase 2DETERMINENCT05124457
DETERMINE: Detemir vs NPH
A Phase 2 study testing Insulin Detemir and Insulin NPH in people with Gestational Diabetes and Diabetes Mellitus, Type 2, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gestational Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Detemir and Insulin NPH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90069
Christina S Han, MD, cshan@mednet.ucla.edu
Michael A Richley, MD, mrichley@mednet.ucla.edu
About this study
Official title: A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Read the detailed description
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Insulin Detemir, Insulin NPH
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DetemirDrug
Patients are to receive insulin detemir
Insulin NPHDrug
Patients are to receive insulin NPH
| Study group | Role | What they receive |
|---|---|---|
| Insulin Detemir | Experimental | Patients are to receive insulin detemir as long acting insulin to control blood sugars Receives: Drug: Insulin Detemir |
| Insulin NPH | Active comparator | Patients are to receive insulin NPH as long acting insulin to control blood sugars Receives: Drug: Insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hypoglycemia
Rate (%) of neonatal hypoglycemia
Measured: Within the first 24 hours of life
Prolonged neonatal hypoglycemia
Rate (%) of prolonged neonatal hypoglycemia
Measured: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge
Secondary outcomes (17)
Neonatal Gastrin Level
Sample form cord blood
Measured: At birth
Neonatal C-Peptide Level
Sample from cord blood
Measured: At birth
Neonatal insulin level
Sample from cord blood
Measured: At birth
Neonatal leptin level
Sample from cord blood
Measured: At birth
Rates of pregnancy induced hypertension
Maternal rates of preeclampsia, eclampsia, or gestational hypertension
Measured: 1 year
Mode of delivery
Spontaneous vaginal, operative vaginal, cesarean
Measured: At delivery
Gestational Age at delivery
Gestational Age at delivery
Measured: At delivery
Maternal glycemic control
Rate (%) of in range maternal blood glucose control in antepartum period
Measured: 1 year
Total daily insulin
Total daily insulin dose in patient
Measured: 1 year
Fetal anomolies
Rate (%) of fetal anomolies
Measured: At birth
Macrosomia
Rate (%) of macrosomia
Measured: At birth
Polyhydramnios
Rate (%) of polyhydramnios
Measured: At birth
Neonatal weight
Neonatal weight
Measured: At birth
Need for supplemental oxygen
Rate of supplemental oxygen use (%) in neonate
Measured: 1 year
Need for dextrose infusion in neonate
Rate of dextrose infusion use (%) in neonate
Measured: 1 year
Rates of respiratory distress syndrome
Rate of RDS (%) in neonate
Measured: 1 year
5 Minute APGAR
5 Minute APGAR
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Feb 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to receive either insulin NPH or insulin detemir
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina S. Han, University of California, Los Angeles
- Investigators
- Christina Han, MD, Principal investigator, University of California, Los AngelesMichael Richley, MD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124457
- Sponsor's protocol ID
- DETERMINE
- Acronym
- DETERMINE
- Status last verified
- Sep 2023
- First submitted
- 25 Oct 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494.
PubMed 26810997Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412.
PubMed 28669379Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.
PubMed 22851598Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015.
PubMed 32396624Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.
PubMed 26070699Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319.
PubMed 11924935O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2.
PubMed 28156005Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238.
PubMed 31498869Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452.
PubMed 28637888Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.
PubMed 33865836Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005.
PubMed 31168280
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study
- ClinicalTrials.gov ID
- NCT05124457
- Acronym / sponsor ID
- DETERMINE / DETERMINE
- Conditions
- Gestational Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Detailed description
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to receive either insulin NPH or insulin detemir
| Arm | Type | Receives |
|---|---|---|
| Insulin Detemir | Experimental | Drug: Insulin DetemirPatients are to receive insulin detemir as long acting insulin to control blood sugars |
| Insulin NPH | Active comparator | Drug: Insulin NPHPatients are to receive insulin NPH as long acting insulin to control blood sugars |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
Key exclusion criteria (9 listed)
- Multiple Gestation
- Type 1 Diabetes mellatus
- Age < 18
- Known or suspected hypersensitivity to NPH or insulin detemir
- Known fetal major malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin DetemirPatients are to receive insulin detemir | Drug | Insulin Detemir |
| Insulin NPHPatients are to receive insulin NPH | Drug | Insulin NPH |
Primary outcome
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
17 secondary outcomes
Neonatal Gastrin Level
Time frame: At birth
Neonatal C-Peptide Level
Time frame: At birth
Neonatal insulin level
Time frame: At birth
Neonatal leptin level
Time frame: At birth
Rates of pregnancy induced hypertension
Time frame: 1 year
Mode of delivery
Time frame: At delivery
Gestational Age at delivery
Time frame: At delivery
Maternal glycemic control
Time frame: 1 year
Total daily insulin
Time frame: 1 year
Fetal anomolies
Time frame: At birth
Macrosomia
Time frame: At birth
Polyhydramnios
Time frame: At birth
Neonatal weight
Time frame: At birth
Need for supplemental oxygen
Time frame: 1 year
Need for dextrose infusion in neonate
Time frame: 1 year
Rates of respiratory distress syndrome
Time frame: 1 year
5 Minute APGAR
Time frame: At birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 26810997Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494.
- Background: PubMed 28669379Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412.
- Background: PubMed 22851598Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.
- Background: PubMed 32396624Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015.
- Background: PubMed 26070699Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.
- Background: PubMed 11924935Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319.
- Background: PubMed 28156005O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2.
- Background: PubMed 31498869Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238.
- Background: PubMed 28637888Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452.
- Background: PubMed 33865836Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.
- Background: PubMed 31168280Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005.
- AbstractLink provided by the sponsor.
- AbstractLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Han, MD principal investigator
University of California, Los Angeles
Michael Richley, MD study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Insulin Detemir and Insulin NPH in people with Gestational Diabetes and Diabetes Mellitus, Type 2, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Richley, MD (310-794-7274, mrichley@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Hypoglycemia (time frame: Within the first 24 hours of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124457, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.