Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.
Brief summary
This study is a Phase 2, randomized, double-blind, placebo-controlled, single-center study in adult patients with type 2 diabetes. It will evaluate the safety and tolerability of oral GLY-200. Subjects will participate in a ≤ 18-day screening period followed by a metformin washout period of approximately 14 days, and an inpatient period of 16 days. Approximately 48 subjects will be randomized to 1 of 3 active treatment groups or 1 of 3 placebo groups. Dosing will occur for 14 days. A follow-up clinic visit will occur on Day 21 \[End of Study (EOS)\] or Early Termination (ET).
Interventions
DRUGGLY-200
0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)
DRUGPlacebo
1 placebo capsule BID for 14 days (n=4)
Sponsors
Glyscend, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients diagnosed with type 2 diabetes: hemoglobin A1c (HbA1c)) ≥ 6.0 and ≤ 8.5% at screening * Body mass index (BMI) ≥ 18 and ≤ 40 at screening Key
Exclusion criteria
* Treated with any prescription medication for the treatment of type 2 diabetes or weight loss other than metformin in the last 3 months prior to screening * Use of any drug treatment that affects gastric pH * Use of any drug treatment that affects gastrointestinal motility * Fasting blood glucose \> 190 mg/dL * Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract or active disease within 12 months prior to screening * History of any previous abdominal or intestinal surgery including endoscopic, open or laparoscopic thoracic or abdominal surgery, surgical resection of the stomach, small or large intestine * Clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] | Over the 14-day treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Glucose | Day 1, Day 7, and Day 14 | Evaluate change from baseline (Day 1) in fasting glucose as captured via continuous glucose monitoring (CGM) at Week 1 and Week 2 |
| Change From Baseline in Fasting Plasma Insulin | Day 1, Day 7, and Day 14 | Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14 |
| Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Day 1, Day 7, and Day 14 | 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. |
| Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Day 1, Day 7, and Day 14 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A metformin washout period was to take place from Day -14 to Day 1 (a total of 14 days).
Participants by arm
| Arm | Count |
|---|---|
| 0.5 g GLY-200 0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days | 14 |
| 1.0 g GLY-200 1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days | 12 |
| 2.0 g GLY-200 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days | 13 |
| 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. | 12 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | COVID-19 Infection | 2 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | 0.5 g GLY-200 | 1.0 g GLY-200 | 2.0 g GLY-200 | Pooled Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 8.74 | 52.5 years STANDARD_DEVIATION 7.29 | 58.1 years STANDARD_DEVIATION 7.72 | 57.6 years STANDARD_DEVIATION 7.99 | 56.3 years STANDARD_DEVIATION 8.04 |
| Body Mass Index (BMI) | 29.84 kg/m^2 STANDARD_DEVIATION 4.624 | 32.04 kg/m^2 STANDARD_DEVIATION 4.849 | 31.82 kg/m^2 STANDARD_DEVIATION 4.094 | 31.68 kg/m^2 STANDARD_DEVIATION 3.168 | 31.29 kg/m^2 STANDARD_DEVIATION 4.219 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 10 Participants | 9 Participants | 9 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 12 Participants | 9 Participants | 40 Participants |
| Region of Enrollment United States | 14 participants | 12 participants | 13 participants | 12 participants | 51 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 5 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 8 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 9 / 14 | 8 / 12 | 12 / 13 | 7 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
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.
Time frame: Over the 14-day treatment period
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.5 g GLY-200 | Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] | 9 Participants |
| 1.0 g GLY-200 | Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] | 8 Participants |
| 2.0 g GLY-200 | Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] | 12 Participants |
| Pooled Placebo | Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] | 7 Participants |
Secondary
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
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.
Time frame: Day 1, Day 7, and Day 14
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 g GLY-200 | 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 |
| 0.5 g GLY-200 | 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 |
| 0.5 g GLY-200 | 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 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 1 | -9.30 mg/dL*hr | Standard Deviation 91.393 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 14 | -66.46 mg/dL*hr | Standard Deviation 168.051 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 7 | -53.19 mg/dL*hr | Standard Deviation 104.891 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 7 | -69.05 mg/dL*hr | Standard Deviation 126.897 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 1 | -17.01 mg/dL*hr | Standard Deviation 82.447 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 14 | -62.53 mg/dL*hr | Standard Deviation 145.027 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 1 | 1.86 mg/dL*hr | Standard Deviation 98.33 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 14 | 47.16 mg/dL*hr | Standard Deviation 124.381 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Glucose Profile | Change from baseline absolute AUC at Day 7 | -2.37 mg/dL*hr | Standard Deviation 106.43 |
Comparison: Analysis at Day 14p-value: 0.029895% CI: [-295.35, -16.01]ANCOVA
Comparison: Analysis at Day 14p-value: 0.043395% CI: [-282.92, -4.55]ANCOVA
Comparison: Analysis at Day 14p-value: 0.020195% CI: [-327.16, -29.5]ANCOVA
Secondary
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
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.
Time frame: Day 1, Day 7, and Day 14
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 g GLY-200 | 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 |
| 0.5 g GLY-200 | 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 |
| 0.5 g GLY-200 | 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 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 14 | -30.11 mU/L*hr | Standard Deviation 54.226 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 1 | -3.15 mU/L*hr | Standard Deviation 45.187 |
| 1.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 7 | -20.84 mU/L*hr | Standard Deviation 41.769 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 1 | -44.18 mU/L*hr | Standard Deviation 77.942 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 7 | -23.00 mU/L*hr | Standard Deviation 52.366 |
| 2.0 g GLY-200 | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 14 | -10.70 mU/L*hr | Standard Deviation 25.343 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 1 | 6.13 mU/L*hr | Standard Deviation 37.07 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 14 | 32.32 mU/L*hr | Standard Deviation 145.992 |
| Pooled Placebo | Change From Baseline in 3-hours Postprandial Plasma Insulin Profile | Change from baseline absolute AUC at Day 7 | 55.72 mU/L*hr | Standard Deviation 198.804 |
Comparison: Analysis at Day 14p-value: 0.199295% CI: [-119.94, 25.81]ANCOVA
Comparison: Analysis at Day 14p-value: 0.061795% CI: [-144.26, 3.61]ANCOVA
Comparison: Analysis at Day 14p-value: 0.298195% CI: [-116.22, 36.53]ANCOVA
Secondary
Change From Baseline in Fasting Glucose
Evaluate change from baseline (Day 1) in fasting glucose as captured via continuous glucose monitoring (CGM) at Week 1 and Week 2
Time frame: Day 1, Day 7, and Day 14
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 1 | -10.04 mg/dL | Standard Deviation 27.966 |
| 0.5 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 2 | -22.56 mg/dL | Standard Deviation 30.842 |
| 1.0 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 2 | -13.23 mg/dL | Standard Deviation 25.009 |
| 1.0 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 1 | -5.68 mg/dL | Standard Deviation 23.202 |
| 2.0 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 1 | -15.61 mg/dL | Standard Deviation 34.16 |
| 2.0 g GLY-200 | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 2 | -14.68 mg/dL | Standard Deviation 33.097 |
| Pooled Placebo | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 1 | 4.86 mg/dL | Standard Deviation 22.16 |
| Pooled Placebo | Change From Baseline in Fasting Glucose | Change from Day 1 at Week 2 | 3.48 mg/dL | Standard Deviation 29.071 |
Comparison: Analysis at Week 2p-value: 0.000795% CI: [-54.35, -15.75]ANCOVA
Comparison: Analysis at Week 2p-value: 0.019395% CI: [-42.32, -3.97]ANCOVA
Comparison: Analysis at Week 2p-value: 0.024395% CI: [-40.33, -2.96]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Insulin
Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14
Time frame: Day 1, Day 7, and Day 14
Population: Per Protocol Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 14 | -1.11 mU/L | Standard Deviation 3.17 |
| 0.5 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 7 | -1.16 mU/L | Standard Deviation 3.36 |
| 0.5 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 1 | -0.25 mU/L | Standard Deviation 2.57 |
| 1.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 14 | -0.74 mU/L | Standard Deviation 3.52 |
| 1.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 1 | -1.17 mU/L | Standard Deviation 3.15 |
| 1.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 7 | -0.76 mU/L | Standard Deviation 3.49 |
| 2.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 7 | -1.18 mU/L | Standard Deviation 3.35 |
| 2.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 1 | 2.03 mU/L | Standard Deviation 3.18 |
| 2.0 g GLY-200 | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 14 | -0.42 mU/L | Standard Deviation 4.49 |
| Pooled Placebo | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 14 | 1.19 mU/L | Standard Deviation 2.36 |
| Pooled Placebo | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 7 | 0.65 mU/L | Standard Deviation 2.84 |
| Pooled Placebo | Change From Baseline in Fasting Plasma Insulin | Change from Baseline at Day 1 | 1.02 mU/L | Standard Deviation 1.92 |