Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy - Clinical Trial for Diabetes Mellitus, Type 2 | NCT03620890

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Neutral Protamine Hagedorn (NPH)

Detemir insulin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

University of Texas Health Science Center of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Neutral Protamine Hagedorn (NPH)

Detemir

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maternal Mean Fasting Glucose

Maternal Mean Post Prandial Glucose

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

Change in Maternal Weight During Pregnancy

Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy

Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.

Number of Maternal Subjects Who Had Preeclampsia With Severe Features

Number of Subjects Who Had Cesarean Delivery

Number of Subjects Who Had Operative Vaginal Delivery

Gestational Weeks 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.

Neonatal Hospital Admission 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.

Number of Neonates Who Had Jaundice Requiring Therapy

Full Information

NCT ID

NCT03620890

First Posted

August 2, 2018

Last Updated

August 20, 2021

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT03620890

Brief Title

Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

Acronym

Determin

Official Title

Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 4, 2018 (Actual)

Primary Completion Date

July 29, 2020 (Actual)

Study Completion Date

July 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

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

Data Monitoring Committee

No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neutral Protamine Hagedorn (NPH)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Detemir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Neutral Protamine Hagedorn (NPH)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Detemir insulin

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Neonates With Composite Adverse Neonatal Outcome

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Maternal Mean Fasting Glucose

Time Frame