Trial Outcomes & Findings for YH1 in Poorly Controlled Type 2 Diabetes (NCT NCT02752880)
NCT ID: NCT02752880
Last Updated: 2019-07-22
Results Overview
The primary efficacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
46 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-07-22
Participant Flow
Participant milestones
| Measure |
YH1 Three Times Per Day for 12 Consecutive Weeks
The YH1 in one batch number was used, manufactured by a renowned GMP manufacturer of concentrated herbal extracts conforming to international standards.
|
Placebo
placebo three times per day for 12 consecutive weeks.
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
YH1 in Poorly Controlled Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
YH1 Group
n=21 Participants
YH1 three times per day for 12 consecutive weeks.
|
Placebo Group
n=20 Participants
placebo three times per day for 12 consecutive weeks.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
56 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
HbA1c
|
8.1 %
n=99 Participants
|
8.7 %
n=107 Participants
|
8.6 %
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe primary efficacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.
Outcome measures
| Measure |
YH1 Group
n=21 Participants
YH1 three times per day for 12 consecutive weeks.
|
Placebo Group
n=20 Participants
placebo three times per day for 12 consecutive weeks.
|
|---|---|---|
|
The Percentage Change in HbA1c Level From Baseline to 12 Weeks
|
-11.1 percentage change
Interval -30.2 to 14.1
|
0.0 percentage change
Interval -20.4 to 7.3
|
SECONDARY outcome
Timeframe: 12 weeksThe secondary efficacy endpoint was the percentage change in 2hPG level from baseline to 12 weeks by using enzymatic method in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.
Outcome measures
| Measure |
YH1 Group
n=21 Participants
YH1 three times per day for 12 consecutive weeks.
|
Placebo Group
n=20 Participants
placebo three times per day for 12 consecutive weeks.
|
|---|---|---|
|
The Percentage Change in 2hPG From Baseline to Week 12
|
-26.2 percentage change
Interval -60.3 to 94.1
|
5.1 percentage change
Interval -43.0 to 90.6
|
Adverse Events
YH1 Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
YH1 Group
n=23 participants at risk
During 12 weeks of YH1 treatment, participants were encouraged to report any discomfort to the project manager throughout the trial. Adverse events including any undesirable or unintended symptoms were assessed regardless of the causal relationship with the study drug.
|
Placebo Group
n=23 participants at risk
During 12 weeks of placebo treatment, participants were encouraged to report any discomfort to the project manager throughout the trial. Adverse events including any undesirable or unintended symptoms were assessed regardless of the causal relationship with the study drug.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal fullness
|
13.0%
3/23 • 3 months
|
13.0%
3/23 • 3 months
|
|
Gastrointestinal disorders
diarrhea
|
30.4%
7/23 • 3 months
|
13.0%
3/23 • 3 months
|
|
General disorders
dizziness
|
0.00%
0/23 • 3 months
|
17.4%
4/23 • 3 months
|
|
Infections and infestations
upper respiratory tract infection
|
17.4%
4/23 • 3 months
|
13.0%
3/23 • 3 months
|
|
Gastrointestinal disorders
nausea
|
13.0%
3/23 • 3 months
|
8.7%
2/23 • 3 months
|
|
Gastrointestinal disorders
acid reflux
|
4.3%
1/23 • 3 months
|
13.0%
3/23 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place