Trial Outcomes & Findings for Actos Now for Prevention of Diabetes (ACT NOW) (NCT NCT00220961)

NCT ID: NCT00220961

Last Updated: 2016-08-11

Results Overview

Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 602 participants
• Primary outcome timeframe: 2.4 years
• Results posted on: 2016-08-11

Participant Flow

Participant milestones

Measure	Placebo Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day	Pioglitazone Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets - 45mg/day tablet
Overall Study STARTED	299	303
Overall Study COMPLETED	228	213
Overall Study NOT COMPLETED	71	90

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Actos Now for Prevention of Diabetes (ACT NOW)

Baseline characteristics by cohort

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets	Total n=602 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	269 Participants n=5 Participants	271 Participants n=7 Participants	540 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 0.5 • n=5 Participants	52.3 years STANDARD_DEVIATION 0.5 • n=7 Participants	52.3 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	127 Participants n=7 Participants	253 Participants n=5 Participants
Sex: Female, Male Male	173 Participants n=5 Participants	176 Participants n=7 Participants	349 Participants n=5 Participants
Region of Enrollment United States	299 participants n=5 Participants	303 participants n=7 Participants	602 participants n=5 Participants

PRIMARY outcome

Timeframe: 2.4 years

Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization

Outcome measures

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Prevention of Type 2 Diabetes	16.1 percentage of participants	5.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline versus 2.4 years

Fasting Plasma Glucose

Outcome measures

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Change From Baseline in Fasting Plasma Glucose of 2.4 Years	-4.0 mg/dl Standard Deviation 0.09	-10.7 mg/dl Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline versus 2.4 years

Insulin secretion

Outcome measures

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test	35 nmol Standard Deviation 5	25 nmol Standard Deviation 4

SECONDARY outcome

Timeframe: Baseline versus 2.4 years

Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.

Outcome measures

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)	0.7 matsuda index Standard Deviation 0.2	3.6 matsuda index Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline versus 2.4 years

carotid intima thickness

Outcome measures

Measure	Placebo n=299 Participants Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 Participants Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Change in Atherosclerosis	1.7 percentage of intima Standard Deviation 0.2	3.2 percentage of intima Standard Deviation 0.2

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 170 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 3 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=299 participants at risk Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 participants at risk Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
General disorders Death	0.33% 1/299 • Number of events 1 • 2.4 years	0.99% 3/303 • Number of events 3 • 2.4 years

Other adverse events

Measure	Placebo n=299 participants at risk Placebo tablet similar to pioglitazone tablet Placebo: Placebo tablets similar to pioglitazone tablets	Pioglitazone n=303 participants at risk Pioglitazone tablet similar to placebo tablet Pioglitazone: Pioglitazone tablets
Cardiac disorders Myocardio infarction, heart failure, other	8.7% 26/299 • Number of events 26 • 2.4 years	7.6% 23/303 • Number of events 23 • 2.4 years
General disorders Other	48.2% 144/299 • Number of events 144 • 2.4 years	23.8% 72/303 • Number of events 72 • 2.4 years

Additional Information

Ralph DeFronzo, MD

University of Texas Health Science Center at San Antonio

Phone: 210-567-6691

Email: defronzo@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place