Back to resultsType 2 Diabetes Patients With Renal Impairment
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
DWP16001
DWP16001
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DWP16001 Single dose
DWP16001 Multiple dose
Arm Description
Single dose
Up to 7 days
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration [Cmax]
Concentration-time curve [AUC]
Urine glucose (g/day)
Cummulative by time
Concentration of serum glucose
Secondary Outcome Measures
Full Information
NCT ID
NCT04221399
First Posted
December 17, 2019
Last Updated
January 6, 2020
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04221399
Brief Title
Type 2 Diabetes Patients With Renal Impairment
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DWP16001 Single dose
Arm Type
Experimental
Arm Description
Single dose
Arm Title
DWP16001 Multiple dose
Arm Type
Experimental
Arm Description
Up to 7 days
Intervention Type
Drug
Intervention Name(s)
DWP16001
Intervention Description
Tablets, Oral, Once daily, Single dose
Intervention Type
Drug
Intervention Name(s)
DWP16001
Intervention Description
Tablets, Oral, Once daily, Multiple dose
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration [Cmax]
Time Frame
on Days 1 to 4 at selected time points
Title
Concentration-time curve [AUC]
Time Frame
on Days 1 to 4 at selected time points
Title
Urine glucose (g/day)
Description
Cummulative by time
Time Frame
on Days -1 to 4
Title
Concentration of serum glucose
Time Frame
on Days 1 to 4 at selected time points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Type 2 Diabetes Patients With Renal Impairment
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