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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 g GLY-200 | Experimental | 0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID) |
|
| 1.0 g GLY-200 | Experimental | 1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID) |
|
| 2.0 g GLY-200 | Experimental | 2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID) |
|
| Placebo for 0.5 g GLY-200 arm | Placebo Comparator | 1 placebo capsule twice a day (BID) |
|
| Placebo for 1.0 g GLY-200 arm | Placebo Comparator | 2 placebo capsules twice a day (BID) |
|
| Placebo for 2.0 GLY-200 arm | Placebo Comparator | 4 placebo capsules twice a day (BID) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLY-200 | Drug | 0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over the 14-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1, Day 7, and Day 14 |
| Change From Baseline in Fasting Plasma Insulin |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fineman, PhD | Glyscend, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento, Inc. | Chula Vista | California | 91911 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40767317 | Derived | Bryant CLN, Colbert K, Hompesch M, Chaves S, Nimgaonkar A, Fineman MS. GLY-200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double-blind placebo-controlled trial. Diabetes Obes Metab. 2025 Oct;27(10):5996-6005. doi: 10.1111/dom.16664. Epub 2025 Aug 6. |
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A metformin washout period was to take place from Day -14 to Day 1 (a total of 14 days).
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 g GLY-200 | 0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days |
| FG001 | 1.0 g GLY-200 | 1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days |
| FG002 | 2.0 g GLY-200 | 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 g GLY-200 | 0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days |
| BG001 | 1.0 g GLY-200 | 1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set | Posted | Count of Participants | Participants | Over the 14-day treatment period |
|
Approximately 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5 g GLY-200 | 0.5 g GLY-200 (1 x 0.5 g capsule) orally twice a day for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashish Nimgaonkar, MD | Glyscend Therapeutics | 6175483513 | ashish.nimgaonkar@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2022 | Jan 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2023 | Jan 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| GLY-200 |
| Drug |
1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12) |
|
| GLY-200 | Drug | 2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12) |
|
| Placebo | Drug | 1 placebo capsule BID for 14 days (n=4) |
|
| Placebo | Drug | 2 placebo capsules BID for 14 days (n=4) |
|
| Placebo | Drug | 4 placebo capsules BID for 14 days (n=4) |
|
Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14
| Day 1, Day 7, and Day 14 |
| 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. | Day 1, Day 7, and Day 14 |
| 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. | Day 1, Day 7, and Day 14 |
| COVID-19 Infection |
|
| BG002 | 2.0 g GLY-200 | 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | 2.0 g GLY-200 | 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days |
| OG003 | 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. |
|
|
| 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 | Full Analysis Set | Posted | Mean | Standard Deviation | mg/dL | Day 1, Day 7, and Day 14 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Insulin | Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14 | Per Protocol Analysis Set | Posted | Mean | Standard Deviation | mU/L | Day 1, Day 7, and Day 14 |
|
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | mg/dL*hr | Day 1, Day 7, and Day 14 |
|
|
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | mU/L*hr | Day 1, Day 7, and Day 14 |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 9 |
| 14 |
| EG001 | 1.0 g GLY-200 | 1.0 g GLY-200 (2 x 0.5 g capsules) orally twice a day for 14 days | 0 | 12 | 0 | 12 | 8 | 12 |
| EG002 | 2.0 g GLY-200 | 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice a day for 14 days | 0 | 13 | 0 | 13 | 12 | 13 |
| EG003 | 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. | 0 | 12 | 0 | 12 | 7 | 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Coronavirus Infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| Change from Day 1 at Week 2 |
|
| 0.0193 |
| LS Mean Difference |
| -23.14 |
| 2-Sided |
| 95 |
| -42.32 |
| -3.97 |
| Superiority |
| Analysis at Week 2 | ANCOVA | 0.0243 | LS Mean Difference | -21.64 | 2-Sided | 95 | -40.33 | -2.96 | Superiority |
| Change from Baseline at Day 7 |
|
| Change from Baseline at Day 14 |
|
| Change from baseline absolute AUC at Day 7 |
|
| Change from baseline absolute AUC at Day 14 |
|
| 0.0433 |
| LS Mean Difference |
| -143.74 |
| 2-Sided |
| 95 |
| -282.92 |
| -4.55 |
| Superiority |
| Analysis at Day 14 | ANCOVA | 0.0201 | LS Mean Difference | -178.33 | 2-Sided | 95 | -327.16 | -29.50 | Superiority |
| Change from baseline absolute AUC at Day 7 |
|
| Change from baseline absolute AUC at Day 14 |
|
| 0.0617 |
| LS Mean Difference |
| -70.32 |
| 2-Sided |
| 95 |
| -144.26 |
| 3.61 |
| Superiority |
| Analysis at Day 14 | ANCOVA | 0.2981 | LS Mean Difference | -39.84 | 2-Sided | 95 | -116.22 | 36.53 | Superiority |