Investigational Study of Delayed Release Metformin
Public ClinicalTrials.gov record NCT04854512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Multicenter, Double-blind, Parallel-Group, Placebo & Comparator-Controlled Study to Compare the Glycemic Effects, Safety & Tolerability of Metformin Delayed-Release Tablets in Patients With Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04854512
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 675 participants
Conditions and interventions
Conditions
Interventions
- Metformin DR Drug
- Metformin IR Drug
- Metformin DR Placebo Drug
- Metformin IR placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2021 (Actual)
- Primary completion
- Dec 1, 2023 (Estimated)
- Completion
- Jun 30, 2024 (Estimated)
- Last update posted
- Mar 14, 2023
2021 – 2024
United States locations
- U.S. sites
- 33
- U.S. states
- 14
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lenzmeier Family Medicine/CCT Research | Glendale | Arizona | 85308 | — |
| Aventiv Research | Mesa | Arizona | 85210 | — |
| Kidney & Hypertension Center / DaVita Clinical Research | Apple Valley | California | 92307 | — |
| California Institute of Renal Research | Chula Vista | California | 91910 | — |
| Academic Medical Research Institute | Los Angeles | California | 90022 | — |
| Valley Renal Medical Group Research | Northridge | California | 91324 | — |
| San Fernando Valley Health Institute | Van Nuys | California | 91405 | — |
| AGA Clinical Trials | Hialeah | Florida | 33012 | — |
| East Coast Institutue for Research | Jacksonville | Florida | 32204 | — |
| East Coast Institute for Research, LLC | Lake City | Florida | 32055 | — |
| West Orange Endocrinology | Ocoee | Florida | 34761 | — |
| Metabolic Research Institute, Inc | West Palm Beach | Florida | 33401 | — |
| Georgia Nephrology Research Institute | Lawrenceville | Georgia | 30046 | — |
| In-Quest Medical Research - Peachtree | Peachtree Corners | Georgia | 30071 | — |
| Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC) | Louisville | Kentucky | 40213 | — |
| Methodist Physicians Clinic / CCT Research | Fremont | Nebraska | 68025 | — |
| Midwest Regional Health Services | Omaha | Nebraska | 68144 | — |
| DaVita Clinical Research | Las Vegas | Nevada | 89128 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | — |
| Lucas Research | Morehead City | North Carolina | 28557 | — |
| Eastern Nephrology Associates | New Bern | North Carolina | 28562 | — |
| Family Medicine of SayeBrook | Myrtle Beach | South Carolina | 29579 | — |
| South Carolina Clinical Research LLC | Orangeburg | South Carolina | 29118 | — |
| WR-ClinSearch | Chattanooga | Tennessee | 37421 | — |
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | — |
| Office of Osvaldo A Brusco, MD | Corpus Christi | Texas | 78414 | — |
| Galenos Research | Dallas | Texas | 75251 | — |
| Endocrine IPS, PLLC | Houston | Texas | 77079 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | — |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | — |
| IACT Health | Suffolk | Virginia | 23435 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04854512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 14, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04854512 live on ClinicalTrials.gov.