Type 2 Diabetes Patients With Renal Impairment

Type2 Diabetes Clinical Trial

Official title:

A Single- and Multiple-Dose Clinical Study to Evaluate Pharmacokinetics and Pharmacodynamics of DWP16001 Following Oral Dose in Type 2 Diabetes Patients With Renal Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04221399
• Other study ID #: DW_DWP16001103
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2020
• Est. completion date: October 2020

Study information

• Verified date: January 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• DWP16001
Tablets, Oral, Once daily, Single dose
• DWP16001
Tablets, Oral, Once daily, Multiple dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration [Cmax]		on Days 1 to 4 at selected time points
Primary	Concentration-time curve [AUC]		on Days 1 to 4 at selected time points
Primary	Urine glucose (g/day)	Cummulative by time	on Days -1 to 4
Primary	Concentration of serum glucose		on Days 1 to 4 at selected time points