A Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of GLY-200 in Type 2 Diabetic Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2023-03-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects

NCT00544921

Diabetes

COMPLETED PHASE1

Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes

NCT02686281

Healthy

TERMINATED PHASE1

Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin

NCT02135549

Type 2 Diabetes Mellitus

COMPLETED NA

Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone

NCT00402909

Type 2 Diabetes

COMPLETED PHASE4

A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes

NCT03560271

Diabetes Mellitus, Type 2

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.5 g GLY-200

0.5 g GLY-200 (1 x 0.5 g capsule) twice a day (BID)

Group Type EXPERIMENTAL

GLY-200

Intervention Type DRUG

0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)

1.0 g GLY-200

1.0 g GLY-200 (2 x 0.5 g capsule) twice a day (BID)

Group Type EXPERIMENTAL

GLY-200

Intervention Type DRUG

1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)

2.0 g GLY-200

2.0 g GLY-200 (4 x 0.5 g capsule) twice a day (BID)

Group Type EXPERIMENTAL

GLY-200

Intervention Type DRUG

2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)

Placebo for 0.5 g GLY-200 arm

1 placebo capsule twice a day (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 placebo capsule BID for 14 days (n=4)

Placebo for 1.0 g GLY-200 arm

2 placebo capsules twice a day (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 placebo capsules BID for 14 days (n=4)

Placebo for 2.0 GLY-200 arm

4 placebo capsules twice a day (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 placebo capsules BID for 14 days (n=4)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GLY-200

0.5 g GLY-200 (1 x 0.5 g capsule) BID for 14 days (n=12)

Intervention Type DRUG

GLY-200

1.0 g GLY-200 (2 x 0.5 g capsules) BID for 14 days (n=12)

Intervention Type DRUG

GLY-200

2.0 g GLY-200 (4 x 0.5 g capsules) BID for 14 days (n=12)

Intervention Type DRUG

Placebo

1 placebo capsule BID for 14 days (n=4)

Intervention Type DRUG

Placebo

2 placebo capsules BID for 14 days (n=4)

Intervention Type DRUG

Placebo

4 placebo capsules BID for 14 days (n=4)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No