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Investigational Study of Delayed Release Metformin

NCT04854512 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2023-03-14

No results posted yet for this study

Summary

In Phase 1 and 2 studies already conducted, Metformin DR, with its targeted delivery to the distal small intestine, has shown the potential to be a safe and effective way to improve glycemic control in patients with T2DM and CKD with less systemic metformin exposure. The primary purpose of this Phase 3 clinical study is to collect pivotal data confirming the safety and efficacy of Metformin DR in T2DM patients with varying renal function from normal up to CKD3B.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Metformin DR

Delay-Release Metformin

DRUG

Metformin IR

Immediate Release Metformin

DRUG

Metformin DR Placebo

Metformin DR Placebo

DRUG

Metformin IR placebo

Metformin IR placebo

Sponsors & Collaborators

  • Anji Pharma

    lead INDUSTRY

Principal Investigators

  • Dan Meyers, MD · Chief Medical Officer - Anji Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2023-12-01
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • Poland
  • Spain

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 NCT04854512 on ClinicalTrials.gov