Trial Outcomes & Findings for Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin (NCT NCT00441363)
NCT ID: NCT00441363
Last Updated: 2016-05-09
Results Overview
Too few subjects were enrolled to assess outcome to pre-specified statistical power.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2016-05-09
Participant Flow
The study was originally designed to enroll 326 subjects in order to randomize 225 subjects. Due to a strategic business decision of the former sponsor (PLIVA), enrollment into the study was prematurely terminated.
Participant milestones
| Measure |
Cycloset
0.8 mg tablet
|
Placebo
matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Cycloset
0.8 mg tablet
|
Placebo
matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Physician Decision
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin
Baseline characteristics by cohort
| Measure |
Cycloset
n=32 Participants
0.8 mg tablet
|
Placebo
n=34 Participants
matching placebo
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
53 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
53 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksToo few subjects were enrolled to assess outcome to pre-specified statistical power.
Outcome measures
| Measure |
Cycloset
n=32 Participants
0.8 mg tablet
|
Placebo
n=34 Participants
matching placebo
|
|---|---|---|
|
Change in Baseline to End of Study in HbA1c
|
-0.4 % HbA1c
Standard Deviation .95
|
-.5 % HbA1c
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 weeksPopulation: Report of Serious adverse events that occurred in the trial.
Outcome measures
| Measure |
Cycloset
n=32 Participants
0.8 mg tablet
|
Placebo
n=34 Participants
matching placebo
|
|---|---|---|
|
Number of Serious Adverse Events Experienced by the Subjects
|
1 serious adverse events
|
0 serious adverse events
|
Adverse Events
Cycloset
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cycloset
n=32 participants at risk
0.8 mg tablet
|
Placebo
n=34 participants at risk
matching placebo
|
|---|---|---|
|
Cardiac disorders
unstable angina
|
3.1%
1/32 • Number of events 1
|
0.00%
0/34
|
Other adverse events
| Measure |
Cycloset
n=32 participants at risk
0.8 mg tablet
|
Placebo
n=34 participants at risk
matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
18.8%
6/32
|
8.8%
3/34
|
|
Gastrointestinal disorders
vomiting
|
9.4%
3/32
|
5.9%
2/34
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
2/32
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.2%
2/32
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32
|
0.00%
0/34
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32
|
5.9%
2/34
|
|
Eye disorders
Vision blurred
|
6.2%
2/32
|
0.00%
0/34
|
|
General disorders
Fatigue
|
6.2%
2/32
|
0.00%
0/34
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32
|
5.9%
2/34
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32
|
5.9%
2/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place