Trial Outcomes & Findings for Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients (NCT NCT00707954)

Last Updated: 2026-01-08

Results Overview

In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

19 days

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	TA-7284 25 mg TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 100 mg TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 200 mg TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 400 mg TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	Placebo Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
Overall Study STARTED	12	12	14	13	10
Overall Study COMPLETED	12	12	14	13	9
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TA-7284 25 mg TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 100 mg TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 200 mg TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 400 mg TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	Placebo Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
Overall Study Physician Decision	0	0	0	0	1

Baseline Characteristics

Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TA-7284 25 mg n=12 Participants TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 100 mg n=12 Participants TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 200 mg n=14 Participants TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 400 mg n=13 Participants TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	Placebo n=10 Participants Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	Total n=61 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 10.6 • n=9 Participants	52.1 years STANDARD_DEVIATION 7.6 • n=6 Participants	56.2 years STANDARD_DEVIATION 8.6 • n=9 Participants	56.5 years STANDARD_DEVIATION 8.2 • n=78 Participants	57.6 years STANDARD_DEVIATION 6.3 • n=16 Participants	54.3 years STANDARD_DEVIATION 8.8 • n=82 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	4 Participants n=78 Participants	2 Participants n=16 Participants	11 Participants n=82 Participants
Sex: Female, Male Male	8 Participants n=9 Participants	12 Participants n=6 Participants	13 Participants n=9 Participants	9 Participants n=78 Participants	8 Participants n=16 Participants	50 Participants n=82 Participants

PRIMARY outcome

Timeframe: 19 days

In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.

Outcome measures

Outcome measures
Measure	TA-7284 100 mg n=12 Participants TA-7284 100 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 200 mg n=14 Participants TA-7284 200 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 400 mg n=13 Participants TA-7284 400 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	Placebo n=10 Participants Placebo was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.	TA-7284 25 mg n=12 Participants TA-7284 25 mg was administered as a single dose, followed by a one-day washout, and multiple doses for 14 days.
Safety: Adverse Events, Adverse Drug Reactions Adverse events	66.7 percentage of incidences	35.7 percentage of incidences	46.2 percentage of incidences	80.0 percentage of incidences	75.0 percentage of incidences
Safety: Adverse Events, Adverse Drug Reactions Adverse drug reactions	16.7 percentage of incidences	7.1 percentage of incidences	7.7 percentage of incidences	30.0 percentage of incidences	50.0 percentage of incidences

SECONDARY outcome

Timeframe: 19 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 days