Type 2 DiabetesPhase 2NCT05478525
A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
A Phase 2 study testing GLY-200 in people with Type 2 Diabetes, run by Glyscend, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GLY-200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2022to 14 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
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).
- Conditions
- Type 2 Diabetes
- Being tested
- GLY-200, Placebo
- Keywords
- Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLY-200Drug
0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)
GLY-200Drug
1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)
GLY-200Drug
2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)
PlaceboDrug
1 placebo capsule BID for 14 days (n=4)
PlaceboDrug
2 placebo capsules BID for 14 days (n=4)
PlaceboDrug
4 placebo capsules BID for 14 days (n=4)
| Study group | Role | What they receive |
|---|---|---|
| 0.5 g GLY-200 | Experimental | 0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID) Receives: Drug: GLY-200 |
| 1.0 g GLY-200 | Experimental | 1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID) Receives: Drug: GLY-200 |
| 2.0 g GLY-200 | Experimental | 2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID) Receives: Drug: GLY-200 |
| Placebo for 0.5 g GLY-200 arm | Placebo comparator | 1 placebo capsule twice a day (BID) Receives: Drug: Placebo |
| Placebo for 1.0 g GLY-200 arm | Placebo comparator | 2 placebo capsules twice a day (BID) Receives: Drug: Placebo |
| Placebo for 2.0 GLY-200 arm | Placebo comparator | 4 placebo capsules twice a day (BID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the 14-day treatment period
Secondary outcomes (4)
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
Measured: Day 1, Day 7, and Day 14
Change From Baseline in Fasting Plasma Insulin
Evaluate change from baseline in fasting plasma insulin at Day 1, Day 7, and Day 14
Measured: 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.
Measured: 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.
Measured: Day 1, Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start3 Aug 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyscend, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Fineman, PhD, Study chair, Glyscend, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478525
- Sponsor's protocol ID
- GLY-200-02
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2022
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40767317
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05478525
- Acronym / sponsor ID
- GLY-200-02
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Diabetes Mellitus, Type 2, GLY-200, Glyscend, Inc.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Glyscend, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.5 g GLY-200 | Experimental | Drug: GLY-2000.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID) |
| 1.0 g GLY-200 | Experimental | Drug: GLY-2001.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID) |
| 2.0 g GLY-200 | Experimental | Drug: GLY-2002.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID) |
| Placebo for 0.5 g GLY-200 arm | Placebo comparator | Drug: Placebo1 placebo capsule twice a day (BID) |
| Placebo for 1.0 g GLY-200 arm | Placebo comparator | Drug: Placebo2 placebo capsules twice a day (BID) |
| Placebo for 2.0 GLY-200 arm | Placebo comparator | Drug: Placebo4 placebo capsules twice a day (BID) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLY-2000.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12) | Drug | 0.5 g GLY-200 |
| GLY-2001.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12) | Drug | 1.0 g GLY-200 |
| GLY-2002.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12) | Drug | 2.0 g GLY-200 |
| Placebo1 placebo capsule BID for 14 days (n=4) | Drug | Placebo for 0.5 g GLY-200 arm |
| Placebo2 placebo capsules BID for 14 days (n=4) | Drug | Placebo for 1.0 g GLY-200 arm |
| Placebo4 placebo capsules BID for 14 days (n=4) | Drug | Placebo for 2.0 GLY-200 arm |
Primary outcome
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200]
Time frame: 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.
4 secondary outcomes
Change From Baseline in Fasting Glucose
Time frame: Day 1, Day 7, and Day 14
Change From Baseline in Fasting Plasma Insulin
Time frame: Day 1, Day 7, and Day 14
Change From Baseline in 3-hours Postprandial Plasma Glucose Profile
Time frame: Day 1, Day 7, and Day 14
Change From Baseline in 3-hours Postprandial Plasma Insulin Profile
Time frame: Day 1, Day 7, and Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40767317Bryant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fineman, PhD study chair
Glyscend, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLY-200 in people with Type 2 Diabetes, run by Glyscend, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events [Safety and Tolerability of GLY-200] (time frame: Over the 14-day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.