Type 2 Diabetes Patients With Renal Impairment

Phase 1

• Conditions: Type2 Diabetes
• Interventions: Drug: DWP16001

• Registration Number: NCT04221399
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-17
• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Study First Posted: 2020-01-09
• Last Update Posted: 2020-01-09
• Primary Completion: 2020-08
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Other exclusive inclusion criteria, as defined in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP16001 Single dose	DWP16001	Single dose
DWP16001 Multiple dose	DWP16001	Up to 7 days

Primary Outcome Measures

Name	Time	Method
Concentration-time curve [AUC]	on Days 1 to 4 at selected time points
Concentration of serum glucose	on Days 1 to 4 at selected time points
Maximum Plasma Concentration [Cmax]	on Days 1 to 4 at selected time points
Urine glucose (g/day)	on Days -1 to 4	Cummulative by time