Diabetes Mellitus, Type 2Phase 4DeterminNCT03620890
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
A Phase 4 study testing Neutral Protamine Hagedorn (NPH) and Detemir insulin in people with Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Neutral Protamine Hagedorn (NPH) and Detemir insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 29 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preexisting type 2 diabetes mellitus requiring medical treatment or
- overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr > 155, 3 hr > 140 mg/dl).
- Gestational age ≤20 weeks
- Willing to start insulin therapy or to continue insulin treatment during pregnancy
- Singleton or twin pregnancy
Who cannot join
- Known allergy/prior adverse reaction to NPH/detemir
- Patients <18y
- Known major fetal anomalies
- Diabetic nephropathy (Creatinine (Cr)≥1.5)
- Diabetic proliferative retinopathy
- Patients with Type 1 diabetes or gestational diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center of Houston
Houston, Texas, 77030
About this study
Official title: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Neutral Protamine Hagedorn (NPH), Detemir insulin
- Keywords
- Pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral Protamine Hagedorn (NPH)Drug
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
Detemir insulinDrug
Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
| Study group | Role | What they receive |
|---|---|---|
| Neutral Protamine Hagedorn (NPH) | Active comparator | NPH will peak between 4-12 hours after injection with a duration of action around 14 hours Receives: Drug: Neutral Protamine Hagedorn (NPH) |
| Detemir | Active comparator | Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) Receives: Drug: Detemir insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Neonates With Composite Adverse Neonatal Outcome
Composite Adverse Neonatal Outcome includes 1 or more of any of the following:
- Neonatal intensive care unit (NICU) admission or
- Neonatal hypoglycemia (<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or
- Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or
- Shoulder dystocia - defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head in order to deliver the fetal body after the fetal head has been delivered or
- Large for gestational age (LGA) -weight over 90th percentile of the expected value according to gestational age or
- Macrosomia- Fetal weight above 4000g
Measured: From the time of delivery to the time of discharge (about 2-14 days)
Secondary outcomes (13)
Maternal Mean Fasting Glucose
Measured: perinatal to postpartum (32 weeks)
Maternal Mean Post Prandial Glucose
Measured: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy
Measured: perinatal to postpartum (32 weeks)
Change in Maternal Weight During Pregnancy
Measured: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy
Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.
Measured: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Had Preeclampsia With Severe Features
Measured: perinatal to postpartum (32 weeks)
Number of Subjects Who Had Cesarean Delivery
Measured: at delivery
Number of Subjects Who Had Operative Vaginal Delivery
Measured: at delivery
Gestational Weeks at Delivery
Measured: at delivery
Number of Neonates Who Where Small for Gestational Age (SGA)
Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.
Measured: at delivery
Neonatal Hospital Admission Days
Measured: From the time of delivery to the time of discharge (about 2-14 days)
# of Neonates Who Had 5-minute Apgar Score < 7
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Measured: 5 minutes after delivery
Number of Neonates Who Had Jaundice Requiring Therapy
Measured: From the time of delivery to the time of discharge (about 2-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start4 Sep 2018
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Fishel Bartal, The University of Texas Health Science Center, Houston
- Investigators
- Michal Fishel Bartal, MD, Principal investigator, University of Texas Health Science Center of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620890
- Sponsor's protocol ID
- HSC-MS-18-0575
- Acronym
- Determin
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2018
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fishel 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 33865836
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03620890
- Acronym / sponsor ID
- Determin / HSC-MS-18-0575
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 18 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral Protamine Hagedorn (NPH) | Active comparator | Drug: Neutral Protamine Hagedorn (NPH)NPH will peak between 4-12 hours after injection with a duration of action around 14 hours |
| Detemir | Active comparator | Drug: Detemir insulinDetemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Preexisting type 2 diabetes mellitus requiring medical treatment or
- overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr > 155, 3 hr > 140 mg/dl).
- Gestational age ≤20 weeks
- Willing to start insulin therapy or to continue insulin treatment during pregnancy
- Singleton or twin pregnancy
Key exclusion criteria (6 listed)
- Known allergy/prior adverse reaction to NPH/detemir
- Patients <18y
- Known major fetal anomalies
- Diabetic nephropathy (Creatinine (Cr)≥1.5)
- Diabetic proliferative retinopathy
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 |
|---|---|---|
| Neutral Protamine Hagedorn (NPH)NPH will peak between 4-12 hours after injection with a duration of action around 14 hours | Drug | Neutral Protamine Hagedorn (NPH) |
| Detemir insulinDetemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) | Drug | Detemir |
Primary outcome
Number of Neonates With Composite Adverse Neonatal Outcome
Time frame: From the time of delivery to the time of discharge (about 2-14 days)
Composite Adverse Neonatal Outcome includes 1 or more of any of the following: * Neonatal intensive care unit (NICU) admission or * Neonatal hypoglycemia (<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or * Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or * Shoulder dystocia - defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head in order to deliver the fetal body after the fetal head has been delivered or * Large for gestational age (LGA) -weight over 90th percentile of the expected value according to gestational age or * Macrosomia- Fetal weight above 4000g
13 secondary outcomes
Maternal Mean Fasting Glucose
Time frame: perinatal to postpartum (32 weeks)
Maternal Mean Post Prandial Glucose
Time frame: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy
Time frame: perinatal to postpartum (32 weeks)
Change in Maternal Weight During Pregnancy
Time frame: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy
Time frame: perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Had Preeclampsia With Severe Features
Time frame: perinatal to postpartum (32 weeks)
Number of Subjects Who Had Cesarean Delivery
Time frame: at delivery
Number of Subjects Who Had Operative Vaginal Delivery
Time frame: at delivery
Gestational Weeks at Delivery
Time frame: at delivery
Number of Neonates Who Where Small for Gestational Age (SGA)
Time frame: at delivery
Neonatal Hospital Admission Days
Time frame: From the time of delivery to the time of discharge (about 2-14 days)
# of Neonates Who Had 5-minute Apgar Score < 7
Time frame: 5 minutes after delivery
Number of Neonates Who Had Jaundice Requiring Therapy
Time frame: From the time of delivery to the time of discharge (about 2-14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michal Fishel Bartal, MD principal investigator
University of Texas Health Science Center of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neutral Protamine Hagedorn (NPH) and Detemir insulin in people with Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 16 Sep 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Neonates With Composite Adverse Neonatal Outcome (time frame: From the time of delivery to the time of discharge (about 2-14 days)). 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 NCT03620890, which also lists 1 linked publication.
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 16 Sep 2021.