Trial Outcomes & Findings for A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients (NCT NCT05478525)
NCT ID: NCT05478525
Last Updated: 2025-02-10
Results Overview
Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in vital signs, clinical laboratory parameters, and electrocardiograms (ECGs) will be recorded as AEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Over the 14-day treatment period
Results posted on
2025-02-10
Participant Flow
A metformin washout period was to take place from Day -14 to Day 1 (a total of 14 days).
Participant milestones
| Measure |
0.5 g GLY-200
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
0.5 g GLY-200
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
COVID-19 Infection
|
2
|
0
|
1
|
1
|
Baseline Characteristics
A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
0.5 g GLY-200
n=14 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 7.29 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 7.99 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 8.04 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
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)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 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
|
1 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
29.84 kg/m^2
STANDARD_DEVIATION 4.624 • n=5 Participants
|
32.04 kg/m^2
STANDARD_DEVIATION 4.849 • n=7 Participants
|
31.82 kg/m^2
STANDARD_DEVIATION 4.094 • n=5 Participants
|
31.68 kg/m^2
STANDARD_DEVIATION 3.168 • n=4 Participants
|
31.29 kg/m^2
STANDARD_DEVIATION 4.219 • n=21 Participants
|
PRIMARY outcome
Timeframe: Over the 14-day treatment periodPopulation: Safety Analysis Set
Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in vital signs, clinical laboratory parameters, and electrocardiograms (ECGs) will be recorded as AEs.
Outcome measures
| Measure |
0.5 g GLY-200
n=14 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
|
9 Participants
|
8 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 7, and Day 14Population: Full Analysis Set
Evaluate change from baseline (Day 1) in fasting glucose as captured via continuous glucose monitoring (CGM) at Week 1 and Week 2
Outcome measures
| Measure |
0.5 g GLY-200
n=14 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Glucose
Change from Day 1 at Week 1
|
-10.04 mg/dL
Standard Deviation 27.966
|
-5.68 mg/dL
Standard Deviation 23.202
|
-15.61 mg/dL
Standard Deviation 34.160
|
4.86 mg/dL
Standard Deviation 22.160
|
|
Change From Baseline in Fasting Glucose
Change from Day 1 at Week 2
|
-22.56 mg/dL
Standard Deviation 30.842
|
-13.23 mg/dL
Standard Deviation 25.009
|
-14.68 mg/dL
Standard Deviation 33.097
|
3.48 mg/dL
Standard Deviation 29.071
|
SECONDARY outcome
Timeframe: Day 1, Day 7, and Day 14Population: Per Protocol Analysis Set
Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14
Outcome measures
| Measure |
0.5 g GLY-200
n=12 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=10 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=11 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Insulin
Change from Baseline at Day 1
|
-0.25 mU/L
Standard Deviation 2.57
|
-1.17 mU/L
Standard Deviation 3.15
|
2.03 mU/L
Standard Deviation 3.18
|
1.02 mU/L
Standard Deviation 1.92
|
|
Change From Baseline in Fasting Plasma Insulin
Change from Baseline at Day 7
|
-1.16 mU/L
Standard Deviation 3.36
|
-0.76 mU/L
Standard Deviation 3.49
|
-1.18 mU/L
Standard Deviation 3.35
|
0.65 mU/L
Standard Deviation 2.84
|
|
Change From Baseline in Fasting Plasma Insulin
Change from Baseline at Day 14
|
-1.11 mU/L
Standard Deviation 3.17
|
-0.74 mU/L
Standard Deviation 3.52
|
-0.42 mU/L
Standard Deviation 4.49
|
1.19 mU/L
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Day 1, Day 7, and Day 14Population: Full Analysis Set
Evaluate change from baseline in Area Under the Curve (AUC) glucose during mixed meal tolerance tests (MMTTs) at Day 1, Day 7, and Day 14. AUC is calculated from -60 to 180 min using the trapezoidal rule.
Outcome measures
| Measure |
0.5 g GLY-200
n=14 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
Change from baseline absolute AUC at Day 1
|
8.48 mg/dL*hr
Standard Deviation 146.856
|
-9.30 mg/dL*hr
Standard Deviation 91.393
|
-17.01 mg/dL*hr
Standard Deviation 82.447
|
1.86 mg/dL*hr
Standard Deviation 98.33
|
|
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
Change from baseline absolute AUC at Day 7
|
-79.21 mg/dL*hr
Standard Deviation 188.194
|
-53.19 mg/dL*hr
Standard Deviation 104.891
|
-69.05 mg/dL*hr
Standard Deviation 126.897
|
-2.37 mg/dL*hr
Standard Deviation 106.430
|
|
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
Change from baseline absolute AUC at Day 14
|
-70.47 mg/dL*hr
Standard Deviation 280.038
|
-66.46 mg/dL*hr
Standard Deviation 168.051
|
-62.53 mg/dL*hr
Standard Deviation 145.027
|
47.16 mg/dL*hr
Standard Deviation 124.381
|
SECONDARY outcome
Timeframe: Day 1, Day 7, and Day 14Population: Full Analysis Set
Evaluate change from baseline in Area Under the Curve (AUC) insulin during mixed meal tolerance tests (MMTTs) at Day 1, Day 7, and Day 14. AUC is calculated from -60 to 180 min using the trapezoidal rule.
Outcome measures
| Measure |
0.5 g GLY-200
n=14 Participants
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 Participants
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 Participants
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 Participants
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
Change from baseline absolute AUC at Day 1
|
-19.49 mU/L*hr
Standard Deviation 38.268
|
-3.15 mU/L*hr
Standard Deviation 45.187
|
-44.18 mU/L*hr
Standard Deviation 77.942
|
6.13 mU/L*hr
Standard Deviation 37.07
|
|
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
Change from baseline absolute AUC at Day 7
|
-20.75 mU/L*hr
Standard Deviation 50.901
|
-20.84 mU/L*hr
Standard Deviation 41.769
|
-23.00 mU/L*hr
Standard Deviation 52.366
|
55.72 mU/L*hr
Standard Deviation 198.804
|
|
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
Change from baseline absolute AUC at Day 14
|
-12.71 mU/L*hr
Standard Deviation 72.558
|
-30.11 mU/L*hr
Standard Deviation 54.226
|
-10.70 mU/L*hr
Standard Deviation 25.343
|
32.32 mU/L*hr
Standard Deviation 145.992
|
Adverse Events
0.5 g GLY-200
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
1.0 g GLY-200
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
2.0 g GLY-200
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5 g GLY-200
n=14 participants at risk
0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days
|
1.0 g GLY-200
n=12 participants at risk
1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days
|
2.0 g GLY-200
n=13 participants at risk
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days
|
Pooled Placebo
n=12 participants at risk
Subjects who received 1, 2, or 4 capsules of placebo (orally twice a day for 14 days) were pooled together as the placebo treatment group.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
57.1%
8/14 • Number of events 8 • Approximately 2 months
|
16.7%
2/12 • Number of events 2 • Approximately 2 months
|
53.8%
7/13 • Number of events 10 • Approximately 2 months
|
25.0%
3/12 • Number of events 4 • Approximately 2 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Approximately 2 months
|
33.3%
4/12 • Number of events 5 • Approximately 2 months
|
53.8%
7/13 • Number of events 13 • Approximately 2 months
|
16.7%
2/12 • Number of events 2 • Approximately 2 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 4 • Approximately 2 months
|
16.7%
2/12 • Number of events 5 • Approximately 2 months
|
69.2%
9/13 • Number of events 69 • Approximately 2 months
|
8.3%
1/12 • Number of events 2 • Approximately 2 months
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Approximately 2 months
|
16.7%
2/12 • Number of events 3 • Approximately 2 months
|
38.5%
5/13 • Number of events 11 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Approximately 2 months
|
16.7%
2/12 • Number of events 2 • Approximately 2 months
|
23.1%
3/13 • Number of events 3 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
2/14 • Number of events 2 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
23.1%
3/13 • Number of events 6 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
|
Infections and infestations
Coronavirus Infection
|
14.3%
2/14 • Number of events 2 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
7.7%
1/13 • Number of events 1 • Approximately 2 months
|
16.7%
2/12 • Number of events 2 • Approximately 2 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • Number of events 2 • Approximately 2 months
|
8.3%
1/12 • Number of events 1 • Approximately 2 months
|
15.4%
2/13 • Number of events 3 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/14 • Approximately 2 months
|
8.3%
1/12 • Number of events 1 • Approximately 2 months
|
23.1%
3/13 • Number of events 3 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
7.7%
1/13 • Number of events 1 • Approximately 2 months
|
16.7%
2/12 • Number of events 4 • Approximately 2 months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/14 • Approximately 2 months
|
0.00%
0/12 • Approximately 2 months
|
15.4%
2/13 • Number of events 3 • Approximately 2 months
|
8.3%
1/12 • Number of events 1 • Approximately 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place