Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-07-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neutral Protamine Hagedorn (NPH)

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

Group Type ACTIVE_COMPARATOR

Neutral Protamine Hagedorn (NPH)

Intervention Type DRUG

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

Detemir

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

Group Type ACTIVE_COMPARATOR

Detemir insulin

Intervention Type DRUG

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

Interventions

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Neutral Protamine Hagedorn (NPH)

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

Intervention Type DRUG

Detemir insulin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No