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Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes

ConditionsDiabetes, GestationalPregnancy ComplicationsGlucose Metabolism DisordersGlucose Intolerance During Pregnancy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorJaeb Center for Health Research

About this trial

Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to provide informed consent for study participation

Age ≥18 years and <41 years old

Singleton pregnancy at 24-34 weeks gestation

Diagnosis of GDM via standard 1-step or 2-step criteria

Disqualifiers

Type 1 diabetes or type 2 diabetes

HbA1c ≥ 6.5%, FBG ≥125 mg/dl or 2-hr glucose ≥200 mg/dL on 75g OGTT, or random plasma glucose ≥200 mg/dL (consistent with pre-existing diabetes and not GDM diagnosis)

Current use of any non-insulin glucose lowering medication

Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Inhaled Technosphere Insulin

    Drug

    Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: technosphere insulin (TI)Experimental treatment 1 intervention
Group B: Rapid-acting insulin analogNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Post-prandial AUC120

3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)

Time frame
3 hours from start of meal

Secondary outcomes

1

AUC >140 mg/dL

AUC \>140 mg/dL over 3 hours PP

Time frame
3 hours from start of meal
2

Excursion from baseline glucose to peak glucose

Excursion from baseline blood glucose to peak blood glucose during 3 hours PP

Time frame
3 hours from start of meal
3

Maximum peak glucose

Maximum peak blood glucose during 3 hours PP

Time frame
3 hours from start of meal
4

Time to peak glucose

Time to peak blood glucose during 3 hours PP

Time frame
3 hours from start of meal

Other outcomes

1

Any blood glucose <54 mg/dL

Any blood glucose \<54 mg/dL during 3 hours PP

Time frame
3 hours from start of meal
2

Any blood glucose <63 mg/dL

Any blood glucose \<63 mg/dL during 3 hours PP

Time frame
3 hours from start of meal
3

Any blood glucose <70 mg/dL

Any blood glucose \<70 mg/dL during 3 hours PP

Time frame
3 hours from start of meal
4

Percent time glucose <63 mg/dL

CGM time with glucose \<63 mg/dL during 3 hours PP

Time frame
3 hours from start of meal

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

Mannkind Corporation

Collaborator

Source ClinicalTrials.gov
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