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Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

ConditionsPancreatic InsufficiencyCystic Fibrosis-related Diabetes
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael R. Rickels, MD, MS

About this trial

This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Male or female, aged ≥18 years on date of consent.

Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.

Disqualifiers

Established diagnosis of non-CF diabetes (e.g. type 1 diabetes).

Pregnancy or lactation; a negative urine pregnancy test will be required at enrollment.

Pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to randomization.

Treatment with either CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, indinavir, ritonavir, saquinavir, telithromycin, boceprevir, nelfinavir, telaprevir, conivaptan, nefazodone, etc.) or inducers (e.g. phenobarbital, other barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, etc.).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dorzagliatin

    Drug

    Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.

  • Placebo

    Drug

    Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: DorzagliatinExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Drug concentrations (PK; Cmax)

Assessed by the peak glucose during a standardized mixed-meal tolerance test following 7-day administration of study drug

Time frame
2 months
2

Glucose tolerance (PD)

Time frame
2 months

Secondary outcomes

1

Early-phase insulin secretion

Assessed by insulin secretory rate and

Time frame
2 months
2

Glucagon suppression

Glucagon incremental area-under-the-curve (iAUC) analyses during the mixed-meal tolerance test following 7-day administration of study drug. iAUC analyses for GLP-1 and GIP will be assessed as potential effect modifiers.

Time frame
2 months

Other outcomes

Sponsors and contacts

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

Michael R. Rickels, MD, MS

Lead sponsor

University of Pennsylvania

Sponsor institution

Source ClinicalTrials.gov
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