Health TrialsbyHealthPanel

Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus

ConditionType I Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOp-T LLC

About this trial

This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Able and willing and able to give informed consent for the trial (separate consent must be obtained for Parts B or C).

Disqualifiers

1. Current malignancy or history of malignancy other than basal cell carcinoma or squamous cell carcinoma in situ.

Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, transient ischemic attack, or arterial insufficiency causing digital gangrene.

Patients with recent immobilization or recent surgery.

Patients with a history of abnormal prothrombotic laboratories such as congenital or inherited deficiency of antithrombin III, protein C, protein S, or confirmed diagnosis of antiphospholipid syndrome.

Trial design

Design model

Sequential

Treatments tested in this trial

  • OPT101

    Drug

    Subcutaneous injection.

  • OPT101 Placebo to Match (PTM)

    Other intervention

    5% Dextrose (w/v)

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: OPT101, 1.0mg/kg, 1.5 mg/kg and 2.0 mg/kgExperimental treatment 1 intervention
Group B: Part B - OPT101 and Placebo to MatchExperimental treatment 2 interventions
Group C: Part C - OPT101 and Placebo to MatchExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in C-peptide (ng/mL)

Change from baseline to End of Study in mixed-meal stimulated C-peptide (ng/mL). The area under the time-C-Peptide curve (AUC) is calculated, and the weighted mean C-peptide is used to convert the measurement back to nanomoles per liter.

Time frame
48-week

Secondary outcomes

1

PK Parameter - Maximum Concentration (Cmax)

Maximum Concentration (Cmax)

Time frame
48-week
2

PK Parameter - Time to reach maximum concentration (Tmax)

Time to reach maximum concentration (Tmax)

Time frame
48-week
3

PK Parameter - terminal half-life t1/2

Terminal half-life t1/2

Time frame
48-week
4

PK Parameter - Area under the curve

Area under the curve (AUC)

Time frame
48-week

Other outcomes

Sponsors and contacts

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

Op-T LLC

Lead sponsor

Source ClinicalTrials.gov
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