Trial Outcomes & Findings for The Role of Apathy in Glycemic Control (NCT NCT00844090)

NCT ID: NCT00844090

Last Updated: 2014-04-21

Results Overview

measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: 6 months from baseline
• Results posted on: 2014-04-21

Participant Flow

recruitment period Oct 2009- Jan 2012.Participants recruited from Omaha VA outpatient clinics

All participants underwent a stress echo after consent. If stress echo was positive patient was not assigned to randomized arms

Participant milestones

Measure	Methylphenidate methylphenidate methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Placebo placebo placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Overall Study STARTED	52	54
Overall Study COMPLETED	46	46
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Apathy in Glycemic Control

Baseline characteristics by cohort

Measure	Methylphenidate n=46 Participants methylphenidate methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Placebo n=46 Participants placebo methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Total n=92 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	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Age, Continuous	54.7 years STANDARD_DEVIATION 9.9 • n=5 Participants	56.0 years STANDARD_DEVIATION 8.4 • n=7 Participants	55.3 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months from baseline

Population: per protocol

measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months

Outcome measures

Measure	Methylphenidate n=46 Participants methylphenidate methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Placebo n=46 Participants placebo Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Change in HbA1c Over Baseline	-1.0 percentage of HbA1c Standard Deviation 1.02	-0.1 percentage of HbA1c Standard Deviation 1.04

Adverse Events

Methyphenidate

Serious events: 7 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methyphenidate n=46 participants at risk methylphenidate methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Placebo n=46 participants at risk placebo Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Cardiac disorders Blood Pressure and pulse	4.3% 2/46 • Number of events 3	4.3% 2/46 • Number of events 2
Gastrointestinal disorders abdominal pain, nausea, loose stool	6.5% 3/46 • Number of events 3	4.3% 2/46 • Number of events 4
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	2.2% 1/46 • Number of events 1	0.00% 0/46
Renal and urinary disorders renal failure	2.2% 1/46 • Number of events 1	2.2% 1/46 • Number of events 1
Infections and infestations cellulitis	0.00% 0/46	2.2% 1/46 • Number of events 1

Other adverse events

Measure	Methyphenidate n=46 participants at risk methylphenidate methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control	Placebo n=46 participants at risk placebo Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control
Gastrointestinal disorders gastrointestinal	43.5% 20/46 • Number of events 32	37.0% 17/46 • Number of events 24
General disorders fatigue	10.9% 5/46 • Number of events 5	15.2% 7/46 • Number of events 7
General disorders dizziness	6.5% 3/46 • Number of events 3	2.2% 1/46 • Number of events 1

Additional Information

Cyrus Desouza MD

Omaha VA Medical Center

Phone: 402-995-5506

Email: cyrus.desouza@va.gov

Results disclosure agreements

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