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Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients with Type 2 Diabetes

NCT05160272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-01-10

No results posted yet for this study

Summary

The aim of this single-center, prospective, randomized, double-blind, placebo-controlled, 2-arm parallel-group interventional study is to investigate the effect of 4-week treatment with AP-325 on C-peptide release as measure of insulin secretion compared to placebo in type 2 diabetes (T2D) patients.

Conditions

  • Type2 Diabetes

Interventions

DRUG

AP-325

Measurement of the effect of AP-325 50mg/d compared to matching placebo after 4-week treatment.

DRUG

Placebo matching AP-325

Measurement of the effect of AP-325 50mg/d compared to matching placebo after 4-week treatment.

Sponsors & Collaborators

  • Algiax Pharmaceuticals GmbH

    collaborator INDUSTRY

  • The Deutsche Diabetes Forschungsgesellschaft e.V.

    lead OTHER

Principal Investigators

  • Michael Roden, MD · Deutsches Diabetes-Zentrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2024-12-17
Completion
2024-12-17

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160272 on ClinicalTrials.gov