Trial Outcomes & Findings for Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus (NCT NCT01191320)
NCT ID: NCT01191320
Last Updated: 2014-07-24
Results Overview
The change in HbA1c from Baseline to 3 Months for each treatment arm
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
3 months
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Androxal 12.5 mg
12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Androxal 25 mg
25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
38
|
38
|
|
Overall Study
COMPLETED
|
36
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Androxal 12.5 mg
n=38 Participants
12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Androxal 25 mg
n=38 Participants
25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 8.7 • 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
|
43 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
38 participants
n=7 Participants
|
38 participants
n=5 Participants
|
119 participants
n=4 Participants
|
|
HgbA1c ratio
|
0.08 Ratio
STANDARD_DEVIATION 0.012 • n=5 Participants
|
0.08 Ratio
STANDARD_DEVIATION 0.013 • n=7 Participants
|
0.09 Ratio
STANDARD_DEVIATION 0.017 • n=5 Participants
|
0.08 Ratio
STANDARD_DEVIATION 0.014 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: ITT population
The change in HbA1c from Baseline to 3 Months for each treatment arm
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Androxal 12.5 mg
n=38 Participants
12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Androxal 25 mg
n=35 Participants
25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
|---|---|---|---|
|
Change in HbA1C
|
0 Ratio
Standard Deviation 0.012
|
0 Ratio
Standard Deviation 0.015
|
0 Ratio
Standard Deviation 0.010
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Androxal 12.5 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Androxal 25 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Androxal 12.5 mg
n=38 participants at risk
12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Androxal 25 mg
n=38 participants at risk
25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
|---|---|---|---|
|
Surgical and medical procedures
Coronary bypass
|
0.00%
0/43
|
0.00%
0/38
|
2.6%
1/38 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
2.3%
1/43 • Number of events 1
|
0.00%
0/38
|
0.00%
0/38
|
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo
Placebo: Placebo capsule 1x daily for 3 months
|
Androxal 12.5 mg
n=38 participants at risk
12.5 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
Androxal 25 mg
n=38 participants at risk
25 mg/day
Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months
|
|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/43
|
5.3%
2/38
|
2.6%
1/38
|
|
Investigations
Glycosylated Hemoglobin increased
|
2.3%
1/43
|
5.3%
2/38
|
0.00%
0/38
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/43
|
5.3%
2/38
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43
|
2.6%
1/38
|
5.3%
2/38
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/43
|
2.6%
1/38
|
5.3%
2/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER