Trial Outcomes & Findings for Effect of Androgel on Type 2 Diabetic Males With Hypogonadism (NCT NCT00350701)

Results Overview

To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

8 weeks

Results posted on

2022-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Androgel 5g androgel 5g androgel: androgel 5g	Androgel 10g androgel 10g androgel 10g: androgel 10g	Placebo placebo placebo: placebo
Overall Study STARTED	17	17	15
Overall Study COMPLETED	17	17	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Androgel 5g n=17 Participants androgel 5g androgel: androgel 5g	Androgel 10g n=17 Participants androgel 10g androgel 10g: androgel 10g	Placebo n=15 Participants placebo placebo: placebo	Total n=49 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Age, Continuous	58 years STANDARD_DEVIATION 8 • n=5 Participants	57 years STANDARD_DEVIATION 9 • n=7 Participants	59 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	49 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

To measure the percent change from baseline at 8 weeks in Nuclear Factor kB DNA binding activity (in arbitrary units normalized to 100% at baseline) between AndroGel and Placebo using electrophoretic mobility shift assay (EMSA). Values at 8 weeks are converted to percent change and compared between the groups

Outcome measures

Outcome measures
Measure	Androgel 5g n=17 Participants androgel 5g androgel: androgel 5g	Androgel 10g n=17 Participants androgel 10g androgel 10g: androgel 10g	Placebo n=15 Participants placebo placebo: placebo
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo baseline	100 Percent change from baseline Standard Deviation 0	100 Percent change from baseline Standard Deviation 0	100 Percent change from baseline Standard Deviation 0
Effect of Androgel Treatment on Relative Nuclear Factor kB Activity Compared to Placebo 8 week	236 Percent change from baseline Standard Deviation 197	82 Percent change from baseline Standard Deviation 61	100 Percent change from baseline Standard Deviation 103

SECONDARY outcome

Timeframe: 8 weeks

Comparison of relative percent change from baseline at 8 weeks in reactive oxygen species generation (measured as arbitrary units normalized to 100% at baseline) in mononuclear cells after either AndroGel or placebo using chemiluminescence PMSF activation assay. Values at 8 weeks are converted to percentage of the baseline and compared between the groups

Outcome measures

Outcome measures
Measure	Androgel 5g n=17 Participants androgel 5g androgel: androgel 5g	Androgel 10g n=17 Participants androgel 10g androgel 10g: androgel 10g	Placebo n=15 Participants placebo placebo: placebo
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo baseline	100 percentage of baseline value Standard Deviation 0	100 percentage of baseline value Standard Deviation 0	100 percentage of baseline value Standard Deviation 0
Effect of Androgel Treatment on Reactive Oxygen Species Generation Compared to Placebo 8 week	91 percentage of baseline value Standard Deviation 8	125 percentage of baseline value Standard Deviation 17	110 percentage of baseline value Standard Deviation 17

SECONDARY outcome

Timeframe: 8 week

To measure the relative percent change from baseline in the inflammatory mediator (CRP) at 8 weeks (values in ng/ml normalized to100% at baseline) following treatment with androgel compared to placebo. Values (in ng/ml) are converted to percentage of baseline at 8 weeks.

Outcome measures

Outcome measures
Measure	Androgel 5g n=17 Participants androgel 5g androgel: androgel 5g	Androgel 10g n=17 Participants androgel 10g androgel 10g: androgel 10g	Placebo n=15 Participants placebo placebo: placebo
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone baseline	100 percentage of baseline value Standard Deviation 0	100 percentage of baseline value Standard Deviation 0	100 percentage of baseline value Standard Deviation 0
Change in Inflammatory Mediator C-Reactive Protein (CRP) Following Treatment With Testosterone 8 week	68 percentage of baseline value Standard Deviation 9	130 percentage of baseline value Standard Deviation 18	95 percentage of baseline value Standard Deviation 10

Adverse Events

Androgel 5g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Androgel 10g

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paresh Dandona

University at Buffalo

Phone: 7165351850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place