Diabetes Mellitus in PregnancyPhase 3NCT06619301
RCT Glargine vs NPH for Treatment of DM in Pregnancy
A Phase 3 study testing Insulin glargine and insulin NPH in people with Diabetes Mellitus in Pregnancy and Type 2 Diabetes Mellitus (T2DM), run by Loyola University at 1 site in United States.
Trial summary
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus, Class A2
- What is being tested?
- Insulin glargine and insulin NPH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Jan 2027
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
- At least 18 years old
- Insulin started prior to 34 weeks gestation
- Established prenatal care by 14 weeks gestation
Who cannot join
- Those under the age of 18 years old
- Those unable to consent in english
- Allergy to insulin
- Controlled with only diet modification or the use of oral antihyperglycemics
- Has diagnosis of Type 1 Diabetes Mellitus
- Receiving insulin through an insulin pump
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
Loyola University Medical Center
Maywood, Illinois, 60153
Joana Lopes Perdigao, MD, 708-216-4033 ext. 2, joana.perdigao@lumc.edu
Nuong Truong, MD, 708-216-4033 ext. 2, nuong.t.truong@luhs.org
About this study
Official title: Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.
Read the detailed description
This is an open-label, noninferiority, prospective randomized study. Patients will be randomized to either be treated with NPH insulin for management of diabetes mellitus in pregnancy, or with Glargine insulin. We will include all pregnant patients managed by the Maternal Fetal Medicine team at Loyola University of Medical Center that have pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin. Our primary outcome is hypoglycemia.
We provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events. Patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in MyLoyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance. The study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the RCT.
- Conditions
- Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus, Class A2
- Being tested
- Insulin glargine, insulin NPH
- Keywords
- Glargine, NPH, Hypoglycemia
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus, Toujeo, Basaglar, Semglee
Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.
insulin NPHDrug
Also called Novolin, Humulin
Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Glargine | Active comparator | Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus. Receives: Drug: Insulin glargine |
| Insulin NPH | Active comparator | Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus. Receives: Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Episodes of hypoglycemia with blood glucose less than 60 mg/dL
Measured: From initiation of insulin therapy to delivery
Secondary outcomes (2)
Large for Gestational Age
Birth weight greater than or equal to the 90th percentile for gestational age
Measured: At delivery
Shoulder dystocia
Diagnosed by delivering providing
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will continue management of diabetes mellitus in pregnancy with whichever medication they randomize to, Glargine or NPH. Analysis will be intention-to-treat.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joana Perdigao, Loyola University
- Investigators
- Joana Lopes Perdigao, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619301
- Sponsor's protocol ID
- 217918
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
PubMed 15855602Smith JG, Manuck TA, White J, Merrill DC. Insulin glargine versus neutral protamine Hagedorn insulin for treatment of diabetes in pregnancy. Am J Perinatol. 2009 Jan;26(1):57-62. doi: 10.1055/s-0028-1095181. Epub 2008 Oct 31.
PubMed 18979406Negrato CA, Rafacho A, Negrato G, Teixeira MF, Araujo CA, Vieira L, Silva CA, Date SK, Demarchi AC, Gomes MB. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study. Diabetes Res Clin Pract. 2010 Jul;89(1):46-51. doi: 10.1016/j.diabres.2010.03.015. Epub 2010 Apr 7.
PubMed 20378197Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet. 2015 Oct;292(4):749-56. doi: 10.1007/s00404-015-3692-3. Epub 2015 Apr 9.
PubMed 25855052Fang YM, MacKeen D, Egan JF, Zelop CM. Insulin glargine compared with Neutral Protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009 Mar;22(3):249-53. doi: 10.1080/14767050802638170.
PubMed 19330710Egerman RS, Ramsey RD, Kao LW, Bringman JJ, Haerian H, Kao JL, Bush AJ. Perinatal outcomes in pregnancies managed with antenatal insulin glargine. Am J Perinatol. 2009 Sep;26(8):591-5. doi: 10.1055/s-0029-1220782. Epub 2009 Apr 15.
PubMed 19370512Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 2007 Apr;114(4):453-7. doi: 10.1111/j.1471-0528.2006.01216.x. Epub 2007 Jan 25.
PubMed 17261126Fishel 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 33865836Herrera 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 26070699Barnett AH. A review of basal insulins. Diabet Med. 2003 Nov;20(11):873-85. doi: 10.1046/j.1464-5491.2003.00996.x.
PubMed 14632712Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.
PubMed 15647580ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
PubMed 30461693
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy
- ClinicalTrials.gov ID
- NCT06619301
- Acronym / sponsor ID
- 217918
- Conditions
- Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus, Class A2
- Keywords
- Glargine, NPH, Hypoglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.
The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.
Detailed description
This is an open-label, noninferiority, prospective randomized study. Patients will be randomized to either be treated with NPH insulin for management of diabetes mellitus in pregnancy, or with Glargine insulin. We will include all pregnant patients managed by the Maternal Fetal Medicine team at Loyola University of Medical Center that have pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin. Our primary outcome is hypoglycemia.
We provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events. Patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in MyLoyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance. The study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient will continue management of diabetes mellitus in pregnancy with whichever medication they randomize to, Glargine or NPH. Analysis will be intention-to-treat.
| Arm | Type | Receives |
|---|---|---|
| Insulin Glargine | Active comparator | Drug: Insulin glargineInsulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus. |
| Insulin NPH | Active comparator | Drug: insulin NPHInsulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
- At least 18 years old
- Insulin started prior to 34 weeks gestation
- Established prenatal care by 14 weeks gestation
Key exclusion criteria (6 listed)
- Those under the age of 18 years old
- Those unable to consent in english
- Allergy to insulin
- Controlled with only diet modification or the use of oral antihyperglycemics
- Has diagnosis of Type 1 Diabetes Mellitus
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 glargineAlso: Lantus, Toujeo, Basaglar, SemgleeInsulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH. | Drug | Insulin Glargine |
| insulin NPHAlso: Novolin, HumulinInsulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin. | Drug | Insulin NPH |
Primary outcome
Hypoglycemia
Time frame: From initiation of insulin therapy to delivery
Episodes of hypoglycemia with blood glucose less than 60 mg/dL
2 secondary outcomes
Large for Gestational Age
Time frame: At delivery
Shoulder dystocia
Time frame: At delivery
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 1 Oct 2024.
- Background: PubMed 15855602Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
- Background: PubMed 18979406Smith JG, Manuck TA, White J, Merrill DC. Insulin glargine versus neutral protamine Hagedorn insulin for treatment of diabetes in pregnancy. Am J Perinatol. 2009 Jan;26(1):57-62. doi: 10.1055/s-0028-1095181. Epub 2008 Oct 31.
- Background: PubMed 20378197Negrato CA, Rafacho A, Negrato G, Teixeira MF, Araujo CA, Vieira L, Silva CA, Date SK, Demarchi AC, Gomes MB. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study. Diabetes Res Clin Pract. 2010 Jul;89(1):46-51. doi: 10.1016/j.diabres.2010.03.015. Epub 2010 Apr 7.
- Background: PubMed 25855052Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet. 2015 Oct;292(4):749-56. doi: 10.1007/s00404-015-3692-3. Epub 2015 Apr 9.
- Background: PubMed 19330710Fang YM, MacKeen D, Egan JF, Zelop CM. Insulin glargine compared with Neutral Protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009 Mar;22(3):249-53. doi: 10.1080/14767050802638170.
- Background: PubMed 19370512Egerman RS, Ramsey RD, Kao LW, Bringman JJ, Haerian H, Kao JL, Bush AJ. Perinatal outcomes in pregnancies managed with antenatal insulin glargine. Am J Perinatol. 2009 Sep;26(8):591-5. doi: 10.1055/s-0029-1220782. Epub 2009 Apr 15.
- Background: PubMed 17261126Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 2007 Apr;114(4):453-7. doi: 10.1111/j.1471-0528.2006.01216.x. Epub 2007 Jan 25.
- 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 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 14632712Barnett AH. A review of basal insulins. Diabet Med. 2003 Nov;20(11):873-85. doi: 10.1046/j.1464-5491.2003.00996.x.
- Background: PubMed 15647580Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- 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.
Joana Lopes Perdigao, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glargine and insulin NPH in people with Diabetes Mellitus in Pregnancy and Type 2 Diabetes Mellitus (T2DM), run by Loyola University 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 4 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: looking for participants now, as of the sponsor's last update on 1 Oct 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Joana Lopes Perdigao, MD (708-216-4033 ext. 2, joana.perdigao@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia (time frame: From initiation of insulin therapy to delivery). 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 NCT06619301, which also lists 13 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 1 Oct 2024.