NCT06144788

Brief Summary

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients with Type 2 Diabetes Mellitus

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2023

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 13, 2023

Last Update Submit

November 17, 2023

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Changes in HbA1c at the 12 week from the baseline

    12 week

Study Arms (3)

JP-2266 Low-dose

EXPERIMENTAL

Subjects take the investigational products once a day for 12 weeks.

Drug: SGLT2 inhibitor

JP-2266 High-dose

EXPERIMENTAL

Subjects take the investigational products once a day for 12 weeks.

Drug: SGLT2 inhibitor

placebo

EXPERIMENTAL

Subjects take the investigational products once a day for 12 weeks.

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitorDRUG

SGLT 1/2 dual inhibitor

Also known as: SGLT 1/2 dual inhibitor
JP-2266 High-doseJP-2266 Low-doseplacebo

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged 19 to 80 years
  • Those diagnosed with type 2 diabetes
  • A person who provides diet and exercise therapy for the management of diabetes from 8 weeks before the screening criteria and can continue diet and exercise therapy during the clinical trial
  • Screening Results of the following criteria
  • % ≤ HbA1c ≤ 10%
  • FPG ≤ 270 mg/dL
  • Patients with 20 \< BMI ≤ 45 kg/㎡
  • Those who voluntarily signed the informed consent to participate in this study

You may not qualify if:

  • Any type of diabetes other than type 2 diabetes
  • Screening when the inspection meets the following criteria
  • AST or ALT more than 3 times the normal upper limit
  • Total bilirubin exceeds twice the normal upper limit
  • eGFR \< 60 mL/min/1.73㎡
  • A person with the following medical history or history of surgery/therapy
  • Medically significant history of kidney disease: kidney vascular obstruction disease, nephrectomy, kidney transplantation, etc
  • History of severe gastrointestinal surgery: total gastrectomy, total colon resection, small intestine resection, gastrointestinal anastomosis, gastrointestinal bypass, etc
  • history of acute pancreatitis or pancreatic surgery
  • History of undergoing bariatric surgery within 2 years before screening
  • Diabetic ketoacidosis, diabetic coma or whole marriage within 1 year prior to screening
  • Urinary tract infections or genital infections within 1 year prior to screening
  • Alcohol or drug addiction within 1 year prior to screening
  • A history of severe heart disease (heart failure, unstable angina, myocardial infarction, congestive heart failure symptoms
  • A person who has a history of significant surgery that causes electrolyte imbalance within 12 weeks before screening, or who is scheduled to undergo significant surgery within 12 weeks after the end of the clinical trial
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 22, 2023

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

KR(1)