Trial Outcomes & Findings for Development of A Novel Anti-Hyperglycemic Agent (NCT NCT00878605)
NCT ID: NCT00878605
Last Updated: 2018-06-14
Results Overview
% change HgbA1c from baseline to 12 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2018-06-14
Participant Flow
Study recruitment commenced on June 1, 2009 under version 1.0 of the protocol, upon approval of the study by the IRB. The first participant was enrolled April 2010, and the last January 2013. Participants received either Cyclo-Z gel 3mg + 20mg zinc; Cyclo-Z gel 9 mg + 20mg zinc; Cyclo-Z gel 15mg + 20mg zinc or Placebo once daily for 12 weeks.
Participant milestones
| Measure |
Arm 1
Placebo control
Placebo: Placebo control
Participants received placebo tablet orally daily for 12 weeks.
|
Arm 2
Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks.
|
Arm 3
Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks.
|
Arm 4
Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of A Novel Anti-Hyperglycemic Agent
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
Placebo control
Placebo: Placebo control
|
Cyclo-Z Gel 3mg + 20 mg Zinc
n=10 Participants
Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Cyclo-Z Gel 9mg + 20 mg Zinc
n=9 Participants
Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Cyclo-Z Gel 15mg + 20 mg Zinc
n=9 Participants
Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
n=5 Participants
|
61.9 years
n=7 Participants
|
63.4 years
n=5 Participants
|
59.5 years
n=4 Participants
|
60.8 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Baseline Demographics
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
38 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12% change HgbA1c from baseline to 12 weeks.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=10 participants at risk
Placebo control
Placebo: Placebo control
|
Arm 2
n=10 participants at risk
Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Arm 3
n=9 participants at risk
Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Arm 4
n=9 participants at risk
Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/9 • 12 weeks
|
11.1%
1/9 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/9 • 12 weeks
|
0.00%
0/9 • 12 weeks
|
Other adverse events
| Measure |
Arm 1
n=10 participants at risk
Placebo control
Placebo: Placebo control
|
Arm 2
n=10 participants at risk
Active medication
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Arm 3
n=9 participants at risk
Active medication efficacy dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
Arm 4
n=9 participants at risk
Active medication high dose
Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/9 • 12 weeks
|
11.1%
1/9 • Number of events 1 • 12 weeks
|
|
Endocrine disorders
Allergic Reaction to Shellfish
|
0.00%
0/10 • 12 weeks
|
0.00%
0/10 • 12 weeks
|
0.00%
0/9 • 12 weeks
|
11.1%
1/9 • Number of events 1 • 12 weeks
|
Additional Information
Dr. Zhaoping Li, Section Chief
VA Greater Los Angeles Healthcare System
Phone: 310-268-3528
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place