Type 2 Diabetes Patients With Renal Impairment

NCT04221399 | Unknown Phase 1

• 1 other identifier: DW_DWP16001103
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the effect of kidney function on pharmacokinetics and pharmacodynamics of DWP16001 following single and multiple oral doses in type 2 diabetes patients with normal kidney function and renal impairment.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration [Cmax]

  on Days 1 to 4 at selected time points

• Concentration-time curve [AUC]

  on Days 1 to 4 at selected time points

• Urine glucose (g/day)

  Cummulative by time

  on Days -1 to 4

• Concentration of serum glucose

  on Days 1 to 4 at selected time points

Study Arms (2)

DWP16001 Single dose

EXPERIMENTAL

Single dose

Drug: DWP16001

DWP16001 Multiple dose

EXPERIMENTAL

Up to 7 days

Drug: DWP16001

Interventions

DWP16001 DRUG

Tablets, Oral, Once daily, Single dose

DWP16001 Single dose

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 19 years at the time of screening test
• Body weight of ≥ 50.0 kg to ≤ 90.0 with a body mass index (BMI) of ≥ 20.0 to ≤ 45.0
• Have been diagnosed with type 2 diabetes

You may not qualify if:

• Have clinically uncontrolled or unstable hepatic, neurological, immune system, respiratory, hemato-oncology, cardiovascular, or psychiatric disorder (subject with chronic disease such as hypertension, diabetes, and hyperlipidemia that is well controlled or stable is eligible to participate in the study based on investigator's judgement)
• History of gastrointestinal diseases, dialysis, kidney transplantation, HIV, hepatitis B or C, acute or chronic infection, recent diabetic ketoacidosis, or gastrointestinal surgery that may affect the absorption of the study drug
• Received SGLT2 inhibitors or drugs of thiazolidinedione class within 6 weeks of scheduled IP administration day
• Clinical laboratory test values are outside the accepted normal range at screening
• AST (SGOT), ALT (SGPT) \> 2 x the upper limit of normal
• Repeatedly confirmed QTc interval \> 450 ms
• Sitting systolic blood pressure \< 80 mmHg or \> 180 mmHg or sitting diastolic blood pressure \< 60 mmHg or \> 110 mmHg after resting for more than 3 minutes

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

Enavogliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 9, 2020
• Study Start: January 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share