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

Glyscend

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: GLY-200; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05478525

GLY-200-02

Details and patient eligibility

About

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).

Enrollment: 51 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 6 patient groups, including a placebo group

0.5 g GLY-200

Experimental group

Description:

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

Treatment:

Drug: GLY-200

Drug: GLY-200

Drug: GLY-200

1.0 g GLY-200

Experimental group

Description:

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

Treatment:

Drug: GLY-200

Drug: GLY-200

Drug: GLY-200

2.0 g GLY-200

Experimental group

Description:

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

Treatment:

Drug: GLY-200

Drug: GLY-200

Drug: GLY-200

Placebo for 0.5 g GLY-200 arm

Placebo Comparator group

Description:

1 placebo capsule twice a day (BID)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo for 1.0 g GLY-200 arm

Placebo Comparator group

Description:

2 placebo capsules twice a day (BID)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo for 2.0 GLY-200 arm

Placebo Comparator group

Description:

4 placebo capsules twice a day (BID)

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo