Trial Outcomes & Findings for A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment (NCT NCT01512849)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

For 72 hours after each administration

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Moderate Renal Impairment Low Dose First TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2	Moderate Renal Impairment High Dose First TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2	Normal Renal Function Low Dose First TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2	Normal Renal Function High Dose First TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
Crossover Period 1 STARTED	6	6	6	6
Crossover Period 1 COMPLETED	6	6	6	6
Crossover Period 1 NOT COMPLETED	0	0	0	0
Crossover Period 2 STARTED	6	6	6	6
Crossover Period 2 COMPLETED	6	6	6	6
Crossover Period 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Population for Moderate Renal Impairment n=12 Participants	Entire Population for Normal Renal Function n=12 Participants	Total n=24 Participants Total of all reporting groups
Age, Continuous	63.7 years FULL_RANGE 10.2 • n=18 Participants	57.8 years FULL_RANGE 9.7 • n=17 Participants	60.8 years n=35 Participants
Sex: Female, Male Female	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Sex: Female, Male Male	12 Participants n=18 Participants	12 Participants n=17 Participants	24 Participants n=35 Participants

PRIMARY outcome

Timeframe: For 72 hours after each administration

Outcome measures

Outcome measures
Measure	Moderate Renal Impairment Low n=12 Participants TA-7284-Low was administered in a single dose.	Moderate Renal Impairment High n=12 Participants TA-7284-High was administered in a single dose.	Normal Renal Function Low n=12 Participants TA-7284-Low was administered in a single dose.	Normal Renal Function High n=12 Participants TA-7284-High was administered in a single dose.
Effect of Renal Function on Maximum Plasma Concentration of TA-7284	1197.1264 ng / mL Standard Deviation 310.5625	2333.3617 ng / mL Standard Deviation 414.8957	1213.6571 ng / mL Standard Deviation 337.8705	2415.6109 ng / mL Standard Deviation 739.8783

PRIMARY outcome

Timeframe: For 72 hours after each administration

Outcome measures

Outcome measures
Measure	Moderate Renal Impairment Low n=12 Participants TA-7284-Low was administered in a single dose.	Moderate Renal Impairment High n=12 Participants TA-7284-High was administered in a single dose.	Normal Renal Function Low n=12 Participants TA-7284-Low was administered in a single dose.	Normal Renal Function High n=12 Participants TA-7284-High was administered in a single dose.
Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284	8766 ng･h/mL Standard Deviation 2551	17835 ng･h/mL Standard Deviation 4434	6929 ng･h/mL Standard Deviation 1734	14815 ng･h/mL Standard Deviation 4162

PRIMARY outcome

Timeframe: For 24 hours after each administration

Outcome measures

Outcome measures
Measure	Moderate Renal Impairment Low n=12 Participants TA-7284-Low was administered in a single dose.	Moderate Renal Impairment High n=12 Participants TA-7284-High was administered in a single dose.	Normal Renal Function Low n=12 Participants TA-7284-Low was administered in a single dose.	Normal Renal Function High n=12 Participants TA-7284-High was administered in a single dose.
Effect of Renal Function on Urinary Glucose Excretion of TA-7284	61.017 g Interval 49.362 to 72.671	70.904 g Interval 59.184 to 82.624	86.592 g Interval 75.612 to 97.572	103.052 g Interval 88.952 to 117.152

PRIMARY outcome

Timeframe: For 24 hours after each administration

The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.

Outcome measures

Outcome measures
Measure	Moderate Renal Impairment Low n=12 Participants TA-7284-Low was administered in a single dose.	Moderate Renal Impairment High n=12 Participants TA-7284-High was administered in a single dose.	Normal Renal Function Low n=12 Participants TA-7284-Low was administered in a single dose.	Normal Renal Function High n=12 Participants TA-7284-High was administered in a single dose.
Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284	60.8 percent of RGR at baseline Interval 52.4 to 69.2	66.5 percent of RGR at baseline Interval 59.5 to 73.5	47.8 percent of RGR at baseline Interval 42.2 to 53.4	52.7 percent of RGR at baseline Interval 45.4 to 60.0

SECONDARY outcome

Timeframe: Upto approximately 14 days after last administration

Other events: 1 other events

Deaths: 0 deaths

Normal Renal Function Low

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Normal Renal Function High

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Moderate Renal Impairment Low n=12 participants at risk TA-7284-Low was administered in a single dose.	Moderate Renal Impairment High n=12 participants at risk TA-7284-High was administered in a single dose.	Normal Renal Function Low n=12 participants at risk TA-7284-Low was administered in a single dose.	Normal Renal Function High n=12 participants at risk TA-7284-High was administered in a single dose.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Gastrointestinal disorders Constipation	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Investigations Blood creatin phosphokinase increased	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Investigations Blood creatinine increased	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Investigations Blood glucose increased	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Investigations Protein urine present	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.
Renal and urinary disorders Pollakiuria	8.3% 1/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.	0.00% 0/12 • Up to approximately 14 days after last administration Serious adverse events and the other adverse events were summarized in terms of renal function and dose.

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER