Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes (NCT NCT02784275)
NCT ID: NCT02784275
Last Updated: 2018-07-12
Results Overview
Change in HbA1c from Day 1 to Week 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-07-12
Participant Flow
Participant milestones
| Measure |
3 mg CHP Plus 23 mg Zinc
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
15
|
|
Overall Study
COMPLETED
|
15
|
16
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
3 mg CHP Plus 23 mg Zinc
n=16 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=16 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=17 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=15 Participants
Placebo
Placebo
|
Total
n=64 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 7.58 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 5.53 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 8.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
15 participants
n=4 Participants
|
64 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However only 54 subjects had Week 12 values (12, 15, 14, and 13 subjects, respectively).
Change in HbA1c from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of HbA1c Level From Baseline
|
-0.21 (%)
Standard Deviation 0.979
|
-0.17 (%)
Standard Deviation 1.038
|
-0.43 (%)
Standard Deviation 1.132
|
-0.04 (%)
Standard Deviation 1.068
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values for weight (12, 15, 14, and 13, respectively).
Change in body weight from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of Body Weight From Baseline
|
-0.73 kg
Standard Deviation 1.524
|
0.61 kg
Standard Deviation 3.4
|
-0.92 kg
Standard Deviation 2.381
|
2.38 kg
Standard Deviation 5.702
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).
Change in fasting plasma glucose from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of Fasting Plasma Glucose Level From Baseline
|
-10.4 mg/dL
Standard Deviation 59.20
|
25.4 mg/dL
Standard Deviation 65.66
|
5.3 mg/dL
Standard Deviation 49.24
|
-23.4 mg/dL
Standard Deviation 95.78
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13 respectively).
Percent of subjects who achieved HbA1c of \<7% at Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving HbA1c Goal of <7.0%
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).
Percent of subjects who achieved HbA1c of \<6% at Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving HbA1c Goal of <6.5%
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 values (12, 14, 14, and 13 respectively).
Change in waist circumference from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change in Waist Circumference From Baseline
|
-0.71 cm
Standard Deviation 6.881
|
-1.31 cm
Standard Deviation 4.099
|
-0.70 cm
Standard Deviation 8.812
|
-0.79 cm
Standard Deviation 5.144
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 postprandial glucose values (11, 14, 14, and 12, respectively).
Change in postprandial (2 hours after dinner) blood glucose levels from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=11 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=12 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline
|
-14.56 mg/dL
Standard Deviation 40.210
|
8.78 mg/dL
Standard Deviation 38.543
|
-5.25 mg/dL
Standard Deviation 62.754
|
-13.95 mg/dL
Standard Deviation 54.262
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 oral glucose tolerance test results (12, 15, 14, and 12, respectively).
Change in oral glucose tolerance test results from Day 1 to Week 12
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=12 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=12 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of Oral Glucose Tolerance Test From Baseline
|
-13.8 mg/dL
Standard Deviation 51.16
|
28.4 mg/dL
Standard Deviation 89.45
|
-19.6 mg/dL
Standard Deviation 85.62
|
-33.6 mg/dL
Standard Deviation 75.72
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 ADDQoL results (9, 15, 14, and 13, respectively).
Individual 19 domains were calculated as a weighted score (WS) for each domain. Average weighted impact score = summing of WS for each domain/19 domains. Total range possible is -9 to 3, and higher number means improvement in quality of life.
Outcome measures
| Measure |
3 mg CHP Plus 23 mg Zinc
n=9 Participants
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=15 Participants
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=14 Participants
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=13 Participants
Placebo
Placebo
|
|---|---|---|---|---|
|
Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline
|
-0.23 Score on a scale
Standard Deviation 2.311
|
0.21 Score on a scale
Standard Deviation 2.171
|
0.35 Score on a scale
Standard Deviation 1.075
|
1.53 Score on a scale
Standard Deviation 2.655
|
Adverse Events
3 mg CHP Plus 23 mg Zinc
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
9 mg CHP Plus 23 mg Zinc
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
15 mg CHP Plus 23 mg Zinc
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 mg CHP Plus 23 mg Zinc
n=15 participants at risk
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=16 participants at risk
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=16 participants at risk
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=14 participants at risk
Placebo
Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
Other adverse events
| Measure |
3 mg CHP Plus 23 mg Zinc
n=15 participants at risk
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Cyclo-Z
|
9 mg CHP Plus 23 mg Zinc
n=16 participants at risk
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Cyclo-Z
|
15 mg CHP Plus 23 mg Zinc
n=16 participants at risk
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Cyclo-Z
|
Placebo
n=14 participants at risk
Placebo
Placebo
|
|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
25.0%
4/16 • Number of events 5 • 14 weeks
|
25.0%
4/16 • Number of events 5 • 14 weeks
|
7.1%
1/14 • Number of events 2 • 14 weeks
|
|
Investigations
Blood insulin increased
|
13.3%
2/15 • Number of events 2 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
12.5%
2/16 • Number of events 2 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
18.8%
3/16 • Number of events 4 • 14 weeks
|
14.3%
2/14 • Number of events 2 • 14 weeks
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
12.5%
2/16 • Number of events 2 • 14 weeks
|
14.3%
2/14 • Number of events 2 • 14 weeks
|
|
Investigations
Blood zinc increased
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
6.2%
1/16 • Number of events 2 • 14 weeks
|
14.3%
2/14 • Number of events 2 • 14 weeks
|
|
Investigations
Cardiac murmur
|
0.00%
0/15 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
14.3%
2/14 • Number of events 2 • 14 weeks
|
|
Investigations
Glucose urine present
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
7.1%
1/14 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
12.5%
2/16 • Number of events 3 • 14 weeks
|
7.1%
1/14 • Number of events 1 • 14 weeks
|
|
Renal and urinary disorders
Polyuria
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Investigations
Haemotocrit decreased
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
7.1%
1/14 • Number of events 1 • 14 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
7.1%
1/14 • Number of events 1 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
12.5%
2/16 • Number of events 2 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
12.5%
2/16 • Number of events 2 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
0.00%
0/14 • 14 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15 • 14 weeks
|
0.00%
0/16 • 14 weeks
|
6.2%
1/16 • Number of events 1 • 14 weeks
|
7.1%
1/14 • Number of events 1 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60