NCT05160272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

January 7, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

January 10, 2025

Status Verified

December 1, 2024

Enrollment Period

2.9 years

First QC Date

November 17, 2021

Last Update Submit

January 9, 2025

Conditions

Type2 Diabetes

Keywords

Type 2 DiabetesDiabetes mellitusGABAA receptorβ-cell functionglycemic control

Outcome Measures

Primary Outcomes (1)

  • Circulating C-peptide by iAUC of C-peptide during an IVGTT

    Change in circulating C-peptide levels from baseline to end of intervention measured by iAUC of C-peptide during an IVGTT until 60th minute (second phase) with AP-325 compared to placebo

    4 weeks

Secondary Outcomes (17)

  • Basal insulin level

    4 weeks

  • C-peptide level

    4 weeks

  • Glucose level

    4 weeks

  • iAUC of circulating insulin (overall)

    4 weeks

  • iAUC of C-peptide level (overall)

    4 weeks

  • +12 more secondary outcomes

Study Arms (2)

AP-325 Treatment

EXPERIMENTAL

AP-325, film-coated tablet, 50mg once daily

Drug: AP-325

Placebo Treatment

PLACEBO COMPARATOR

Placebo matching AP-325 film-coated tablet, once daily

Drug: Placebo matching AP-325

Interventions

AP-325DRUG

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

AP-325 Treatment
Placebo matching AP-325DRUG

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

Placebo Treatment

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of T2D
  • Age between 25 and 75 years
  • HbA1c ≥6.5 and ≤9.5 %
  • BMI ≤ 45 kg/m2
  • Treatment-naive or stable antihyperglycemic therapy with metformin, α-glucosidase-inhibitor and/or SGLT2 inhibitor
  • Ability to give consent

You may not qualify if:

  • Acute infections (hsCRP \> 5mg/dl, body temperature \>37.5°C)
  • Insulin therapy or treatment with sulfonylureas, glinides, GLP-1 receptor agonists, thiazolidinediones; current treatment with DPP-4 inhibitors or during the 4 weeks prior to baseline examination
  • Uncontrolled hyperglycemia, e.g. fasting blood glucose \>240 mg/dl
  • Heart rate \<50 or \>100 beats per minute; systolic blood pressure \<100 or \>160 mmHg; diastolic blood pressure \<50 or \>100 mmHg; uncontrolled hypertension
  • Creatinine clearance \<60 ml/min (eGFR by MDRD formula)
  • Severe chronic illnesses, such as congestive heart failure (NYHA III/IV), liver insufficiency (Child-Pugh Class B/C), history of acute coronary syndrome, stroke
  • Anemia (Hb \<12 g/l for men, Hb \<11 g/l for women)
  • Participation in another intervention study within 2 months before the examination
  • Hypersensitivity against AP-325, placebo or other ingredients of IMP
  • Immunocompromising diseases
  • Immunomodulatory drugs (e.g. oral cortisone preparations, biologicals)
  • Thyroid diseases with an unstable metabolic state (change in L-thyroxine dose within the past 6 weeks, TSH and fT4 outside the normal range)
  • Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method
  • Past (≤ 5 years) or current history of psychiatric disorders, including psychiatric depression
  • HIV, hepatitis B or C disease
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Roden, MD

    Deutsches Diabetes-Zentrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 16, 2021

Study Start

January 7, 2022

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

January 10, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)