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

G

Glyscend

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo
Drug: GLY-200

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

52 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: HbA1c ≥ 6.0 and ≤ 8.5% at screening
  • 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 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

52 participants in 6 patient groups, including a placebo group

0.5 g GLY-200
Experimental group
Treatment:
Drug: GLY-200
1.0 g GLY-200
Experimental group
Treatment:
Drug: GLY-200
2.0 g GLY-200
Experimental group
Treatment:
Drug: GLY-200
Placebo for 0.5 g GLY-200 arm
Placebo Comparator group
Treatment:
Drug: Placebo
Placebo for 1.0 g GLY-200 arm
Placebo Comparator group
Treatment:
Drug: Placebo
Placebo for 2.0 GLY-200 arm
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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