NCT03790839

Brief Summary

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

February 28, 2023

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

December 27, 2018

Last Update Submit

February 23, 2023

Conditions

Patients

Outcome Measures

Primary Outcomes (8)

  • Geometric mean ratio (GMR) for Cmax of sitagliptin

    GMR between combination and sitagliptin monotherapy for Cmax of sitagliptin

    up to 10 days

  • GMR for AUC0-24h of sitagliptin

    GMR between combination and sitagliptin monotherapy for AUC0-24h of sitagliptin

    up to 10 days

  • GMR for Cmax of dorzagliatin

    GMR between combination and dorzagliatin monotherapy for Cmax of dorzagliatin

    up to 15 days

  • GMR for AUC0-24h of dorzagliatin

    GMR between combination and dorzagliatin monotherapy for AUC0-24h of dorzagliatin

    up to 15 days

  • Adverse events

    Number of participants with AEs

    up to 15 days

  • Abnormal vital signs

    Number of participants with abnormal vital signs (blood pressure, pulse rate, respiratory rate and oral temperature)

    up to 15 days

  • Abnormal clinical laboratory findings

    Number of participants with abnormal clinical laboratory findings

    up to 15 days

  • 12-lead ECG

    Number of participants with abnormal ECG VR,, PR, QRS and QT

    up to 15 days

Secondary Outcomes (6)

  • iCmax of glucose

    up to 15 days

  • iAUC0-4h of glucose

    up to 15 days

  • iCmax of C-peptide

    up to 15 days

  • iAUC0-4h of C-peptide

    up to 15 days

  • iCmax of GLP-1

    up to 15 days

  • +1 more secondary outcomes

Study Arms (1)

Sequential arm ABC

EXPERIMENTAL

A: Sitagliptin 100 mg QD in the morning on Days 1-5; B: Sitagliptin 100 mg QD in the morning and dorzagliatin 75 mg BID (morning and evening) on Days 6-10, with only the morning dose on Day 10; C: Dorzagliatin 75 mg BID (morning and evening) on Days 11-15, with only the morning dose on Day 15.

Drug: SitagliptinDrug: Dorzagliatin

Interventions

SitagliptinDRUG

Sitagliptin (Januvia® 100 mg tablets for oral administration)

Also known as: Januvia
Sequential arm ABC
DorzagliatinDRUG

Glucokinase activator currently under development

Also known as: HMS5552
Sequential arm ABC

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with T2DM within at least 3 months prior to screening
  • Male and/or female subjects between the ages of 30 and 65 years, inclusive;
  • Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive;
  • Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
  • HbA1c ≥7% and ≤10.5%;

You may not qualify if:

  • Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
  • Type 1 diabetes mellitus;
  • Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
  • Known contraindications to sitagliptin;
  • Clinically significant gastrointestinal disorder;
  • History or symptoms of clinically significant cardiovascular disease within one year prior to screening;
  • History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
  • Reported history of clinically significant central nervous system disease;
  • Reported history of liver disease;
  • Reported history of clinically significant renal disease;
  • Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  • Known or suspected malignancy;
  • Any reported hypersensitivity or intolerance to sitagliptin;
  • Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frontage Clinical Services Inc.

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Sitagliptin PhosphateDorzagliatin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Gregory Tracey, MD

    Frontage Clinical Services, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

January 2, 2019

Study Start

January 31, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

February 28, 2023

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)