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=18 Participants	52.1 years STANDARD_DEVIATION 7.6 • n=17 Participants	56.2 years STANDARD_DEVIATION 8.6 • n=35 Participants	56.5 years STANDARD_DEVIATION 8.2 • n=42 Participants	57.6 years STANDARD_DEVIATION 6.3 • n=217 Participants	54.3 years STANDARD_DEVIATION 8.8 • n=1518 Participants
Sex: Female, Male Female	4 Participants n=18 Participants	0 Participants n=17 Participants	1 Participants n=35 Participants	4 Participants n=42 Participants	2 Participants n=217 Participants	11 Participants n=1518 Participants
Sex: Female, Male Male	8 Participants n=18 Participants	12 Participants n=17 Participants	13 Participants n=35 Participants	9 Participants n=42 Participants	8 Participants n=217 Participants	50 Participants n=1518 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 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.
Safety: Adverse Events, Adverse Drug Reactions Adverse drug reactions	50.0 percentage of incidences	16.7 percentage of incidences	7.1 percentage of incidences	7.7 percentage of incidences	30.0 percentage of incidences
Safety: Adverse Events, Adverse Drug Reactions Adverse events	75.0 percentage of incidences	66.7 percentage of incidences	35.7 percentage of incidences	46.2 percentage of incidences	80.0 percentage of incidences

SECONDARY outcome

Timeframe: 19 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 days