Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

NCT03620890 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-18-0575
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

  From the time of delivery to the time of discharge (about 2-14 days)

Secondary Outcomes (13)

• Maternal Mean Fasting Glucose

  perinatal to postpartum (32 weeks)

• Maternal Mean Post Prandial Glucose

  perinatal to postpartum (32 weeks)

• Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy

  perinatal to postpartum (32 weeks)

• Change in Maternal Weight During Pregnancy

  perinatal to postpartum (32 weeks)

• Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy

  perinatal to postpartum (32 weeks)

Study Arms (2)

Neutral Protamine Hagedorn (NPH)

ACTIVE COMPARATOR

NPH will peak between 4-12 hours after injection with a duration of action around 14 hours

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)

Drug: Detemir insulin

Interventions

Neutral Protamine Hagedorn (NPH) DRUG

NPH will peak between 4-12 hours after injection with a duration of action around 14 hours

Neutral Protamine Hagedorn (NPH)

Detemir insulin DRUG

Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)

Detemir

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 33865836 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin, Isophane; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michal Fishel Bartal, MD, Assistant Professor
• Organization: The University of Texas Health Science Center at Houston

Michal.F.Bartal@uth.tmc.edu

713-500-6421

Study Officials

• Michal Fishel Bartal, MD

  University of Texas Health Science Center of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of OB GYN

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 8, 2018
• Study Start: September 4, 2018
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: September 16, 2021
• Results First Posted: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)