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Diabetes Mellitus, Type 2Phase 3DREAM-T2DNCT04854512

Investigational Study of Delayed Release Metformin

A Phase 3 study testing Metformin DR and Metformin IR in people with Diabetes Mellitus, Type 2, run by Anji Pharma at 87 sites in 8 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin DR and Metformin IR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
675 participants
Where
87 sitesin 8 countries
Study dates
18 May 2021to 30 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is male or female and at least 18 years old
  • Has body mass index 20.0 to 45.0 kg/m2 (inclusive)
  • Has T2DM
  • Has HbA1c of 7.0% to 9.5%, inclusive, at Visit 1A and HbA1c value of 7.0% to 10.5%, inclusive, at Week -2 (Visit 3/3A as applicable)
  • Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation at Visit 1A and Visit 3/3A (Week -2)
  • Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A
Show all 15Show fewer
  • If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B
  • Drugs known to affect body weight, including prescription medications (e.g., phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone) and over-the-counter anti-obesity agents
  • Hormone replacement therapy (female patients) and testosterone (male patients)
  • Oral contraceptives (female patients)
  • Antihypertensive agents including ACEi/ARB
  • Lipid-lowering agents
  • Thyroid replacement therapy
  • Antidepressant agents
  • Ability to understand and willingness to adhere to protocol requirements

Who cannot join

  • Is currently on dialysis, has been on any dialysis within 1 year of Visit 1B, or is expected to undergo dialysis during the study period
  • Has a history of lactic acidosis
  • Has a fasting plasma glucose (FPG) value >240 mg/dL (>13.3 mmol/L) at Week -2 (Visit 3/3A as applicable)
  • An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN at Visit 1B or Visit 3/3A (Week -2) (except in case of documented Gilbert's syndrome)
  • Has a fasting plasma lactate value >2 mol at Visit 1B
  • Has a bicarbonate value ≤20 mEq/L at both Visit 1A and 1B. If bicarbonate value is <20 at Visit 3/3A or 4, patient may be excluded if the investigator considers this clinically significant
Show all 34Show fewer
  • A history of >5% weight change within 12 weeks prior to Visit 1A
  • Has mean BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP) at Visit 1A or Visit 3/3A, which can be rechecked within 1 week (Note: re-screening is allowed 6 weeks after initiation/modification of antihypertensive agents if the patient is screen failed due to BP only)
  • Oral antidiabetic agent or insulin use that is not stable for 8 weeks prior to randomization (i.e., change in oral medication dose or basal insulin dose increased or decreased by more than 20% during the 8 weeks prior to Visit 4 [Day 1])
  • Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
  • Prescribed metformin preparation after initiation of metformin washout following Visit 1B
  • Greater than 10 consecutive days of systemic corticosteroids by oral, intravenous, or intramuscular route within 12 weeks of Visit 1B; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary
  • Planned use of proton pump inhibitors after Visit 2 (Week -6); such use could potentially affect the DR and PK of Metformin DR. Proton pump inhibitor treatment may be replaced by other treatment (such as H2 receptor antagonists [excluding ranitidine], or calcium carbonate antacids) prior to Visit 4 (Day 1), if appropriate per the judgment of the Investigator
  • Cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, flecainide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) within 1 week of Visit 3 (Week 2)
  • Iodinated contrast dye within 1 week prior to Visit 3 (Week -2)
  • Investigational drug within 8 weeks (or 5 half-lives of the investigational drug, whichever is greater) of the date of the first dose of randomized study medication
  • Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B
  • Has a clinically significant medical condition as judged by the Investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:
  • Hepatic disease
  • Gastrointestinal disease, including but not limited to:
  • History or presence of inflammatory bowel disease or other severe gastrointestinal disease, particularly those that may impact gastric emptying, such as gastroparesis and pyloric stenosis ii. Prior or expected surgical gastrointestinal procedure that may impact the gut hormonal response to study medication such as gastric bypass surgery or gastric banding surgery iii. Active diagnosis of pancreatitis c. Endocrine disorder other than T2DM or hypothyroidism on replacement therapy d. Cardiovascular disease, including history of stroke, decompensated heart failure New York Heart Association Class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty within 3 months prior to Visit 1A (screening) e. Central nervous system diseases such as epilepsy f. Psychiatric or neurological disorders that in the Investigator's opinion would cause the patient to be noncompliant with study procedures g. Organ transplantation h. Chronic or acute infection requiring systemic antibiotic treatment i. Orthostatic hypotension or syncope j. Active malignancy within the past 5 years with exception of basal cell and squamous cell carcinoma
  • Known allergy or hypersensitivity to Metformin DR, Metformin IR, or placebo or any inactive component of study medication, active comparator, or placebo, unless the reaction is deemed irrelevant to the study by the Investigator (prior history of gastrointestinal intolerance to metformin is not exclusionary)
  • Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B
  • A physical, psychological, or historical finding that, in the Investigator's opinion, would make the patient unsuitable for the study
  • Any verified clinically significant abnormality identified on physical examination, laboratory tests, ECG, vital signs, or any adverse event (AE) at the time of Visit 1B through Visit 4 that, in the judgment of the Investigator or any Sub-investigator, would preclude safe completion of the study or constrains efficacy assessment
  • Currently abuses drugs or alcohol or has a known history of abuse that in the Investigator's opinion would cause the patient to be noncompliant with study procedures
  • Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 8 weeks prior to Visit 1B, or is planning to donate blood or have a blood transfusion during the study
  • Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B
  • Patients insufficiently compliant with study medication during the placebo run-in phase (<85% or >115%) as assessed at Visit 4
  • Is screening for the study at more than one clinical site or is participating in any other clinical study
  • Is currently pregnant (confirmed by serum pregnancy test at Visit 1B) or breastfeeding or plans to become pregnant during the course of the study
  • Women of childbearing potential not willing to use highly effective method(s) of birth control during the entire study, or who are unwilling or unable to be tested for pregnancy
  • If the patient has evidence of coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection), the patient cannot be enrolled in the study
  • Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company).

Trial locations and contacts

87 sites in 8 countries.

87 sites in 8 countries

United States33 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Kidney & Hypertension Center / DaVita Clinical Research

    Apple Valley, California, 92307

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • California Institute of Renal Research

    Chula Vista, California, 91910

  • Office of Osvaldo A Brusco, MD

    Corpus Christi, Texas, 78414

  • Galenos Research

    Dallas, Texas, 75251

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Methodist Physicians Clinic / CCT Research

    Fremont, Nebraska, 68025

  • Lenzmeier Family Medicine/CCT Research

    Glendale, Arizona, 85308

  • AGA Clinical Trials

    Hialeah, Florida, 33012

  • Endocrine IPS, PLLC

    Houston, Texas, 77079

  • East Coast Institutue for Research

    Jacksonville, Florida, 32204

  • East Coast Institute for Research, LLC

    Lake City, Florida, 32055

  • DaVita Clinical Research

    Las Vegas, Nevada, 89128

  • Georgia Nephrology Research Institute

    Lawrenceville, Georgia, 30046

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC)

    Louisville, Kentucky, 40213

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Aventiv Research

    Mesa, Arizona, 85210

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Family Medicine of SayeBrook

    Myrtle Beach, South Carolina, 29579

  • Eastern Nephrology Associates

    New Bern, North Carolina, 28562

  • Valley Renal Medical Group Research

    Northridge, California, 91324

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Midwest Regional Health Services

    Omaha, Nebraska, 68144

  • South Carolina Clinical Research LLC

    Orangeburg, South Carolina, 29118

  • In-Quest Medical Research - Peachtree

    Peachtree Corners, Georgia, 30071

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • IACT Health

    Suffolk, Virginia, 23435

  • San Fernando Valley Health Institute

    Van Nuys, California, 91405

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida, 33401

Other trials in United States

Brazil10 sites

  • Universidade Federal Do Para (UFPA) - Insitituto de Ciencas de Saude (ICS)

    Belém, Pará

  • Loema - Instituto de Pesquisa Clinica

    Campinas, São Paulo, 13060-400

  • Instituto de Pesquisa Clinica de Campinas

    Campinas, São Paulo

  • Centro de Diabetes Curitiba

    Curitiba, Paraná

  • Cline Research Center

    Curitiba, Paraná

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza, Ceará, 60170-320

  • Centro de Pesquisas em Diabetes e Doencas Endrocrino-Metabolica Ltda

    Fortaleza, Ceará

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Centro de Pesquisas em Diabetes Ltda

    Porto Alegre, Rio Grande do Sul

  • IBPClin Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, Rio de Janeiro

Other trials in Brazil

Poland9 sites

  • Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Internistyczno-Diabetologiczny

    Bialystok, 15-435

  • Centrum Medyczne Pratia

    Katowice, 40-081

  • Pro Familia Altera Sp. z.o.o.

    Katowice, 40-648

  • Malopolskie Centrum Kliniczne

    Krakow, Lesser Poland Voivodeship, 30-149

  • Diamond Medical Center

    Krakow, 31-559

  • NZOZ NEUROMED M.iM. Nastaj Sp.P.

    Lublin, Lublin Voivodeship, 20-064

  • NBR Polska

    Warsaw, 00-0465

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw, 02-507

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy

    Wroclaw, 51-162

Other trials in Poland

Canada8 sites

  • LMC Manna Research (Barrie)

    Barrie, Ontario, L4N 7L3

  • LMC Manna Research (Brampton)

    Brampton, Ontario, L6S 0C6

  • Stephen S. Chow Medicine Professional Corporation

    East York, Ontario, M4C 5T2

  • LMC Manna Research (Etobicoke)

    Etobicoke, Ontario, M9R 4E1

  • LMC Manna Research (Montreal)

    Montreal, Quebec, H4T 1Z9

  • LMC Manna Research (Ottawa)

    Nepean, Ontario, K2J 4A7

  • LMC Manna Research (Bayview)

    Toronto, Ontario, M4G 3E8

  • BC Diabetes

    Vancouver, British Columbia, V5Y 3W2

Other trials in Canada

Hungary8 sites

  • Lausmed Kft

    Baja, 6500

  • Principal SMO Ltd

    Baja, 6500

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Bajscy-Zsilinszky Hospital

    Budapest, 1106

  • Magyar Honvedseg Egeszsegugyl Koxpont

    Budapest, 1134

  • Borbanya Praxis EU k ft

    Debrecen, 4025

  • Borbanya Praxis EU Kft

    Nyíregyháza, SZ, 4405

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Bulgaria7 sites

  • ASOMC Endocrinology and Metabolic Diseases

    Rousse, 7002

  • Medical Cetner Teodora

    Rousse, 7003

  • Multiprofile Hospital for Active Treatment

    Smolyan, 4700

  • Fourth Multipfoile Hospital for Active Treatment

    Sofia, 1606

  • Medical Center New Rehabilition Cetner EOOD

    Stara Zagora, 6000

  • Diagnostic Culsultative Cetner "Equita" EOOD

    Varna, 9000

  • Medical Center Leo Clinical EOOD

    Varna, 9020

Other trials in Bulgaria

Czechia7 sites

  • Diahaza s.r.o.

    Holešov, 769 01

  • Diabetologicka ambulance

    Krnov, 794 01

  • Interni Ambulance

    Olomouc, 77900

  • Endodiab s.r.o.

    Prague, 104 00

  • Diabet2 s.r.o.

    Prague, 110 00

  • Diabetologicka a podiatricka ambulance, Milan Kvapil s.r.o.

    Prague, 149 00

  • ResTrial s.r.o.

    Prague, 181 00

Other trials in Czechia

Spain5 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen del Rocio

    Seville, SE, 41013

  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003

  • Hospital Vithas Sevilla

    Seville, 41950

Other trials in Spain

About this study

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

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.

Read the detailed description

The study is a multicenter, international study with a 28 week randomized, double blind parallel group, placebo and active comparator controlled period and a 24 week open label extension period in patients with T2DM who are treated with metformin at the time of study screening.

Approximately 675 patients will be randomly assigned to 1 of 3 treatment groups. The study will assess change in HbA1c through 28 weeks for Metformin DR compared to placebo as a primary endpoint. In addition, assessments of change in HbA1c for Metformin DR compared to Metformin IR and assessment of absolute change in HbA1c will be evaluated in the study.

Screening and Run-in Period:

The study will include an up to 10-day screening period, an 4 to 8-week metformin washout period, and a 2-week single blind (patient blinded) placebo run-in period.

Treatment Period:

Patients that are determined eligible based upon the screening and run-in criteria will enter the 28-week double-blind treatment period. During the double-blind treatment period, patients will be randomly assigned to 1 of 3 treatment groups (Group A, B, or C) in a 1:1:1 ratio. The 3 treatments are Metformin DR (1800 mg Metformin DR with matching placebo for Metformin IR), Metformin IR (1500 mg Metformin IR with matching placebo for Metformin DR), and placebo (matching placebo for Metformin IR with matching placebo for Metformin DR). For those patients randomized to Metformin IR, their Metformin IR dose will be titrated to prevent gastrointestinal intolerability:

Open Label Extension Period:

Upon completion of the 28 week treatment patients will be eligible for an additional 24 weeks of open label extension period where assigned study treatment will continue and additional efficacy, safety and tolerability data will be collected and analyzed.

Being tested
Metformin DR, Metformin IR, Metformin DR Placebo, Metformin IR placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin DRDrug

    Also called ANJ900, MetDR

    Delay-Release Metformin

  • Metformin IRDrug

    Immediate Release Metformin

  • Metformin DR PlaceboDrug

    Metformin DR Placebo

  • Metformin IR placeboDrug

    Metformin IR placebo

Study groups in NCT04854512
Study groupRoleWhat they receive
Investigational Arm (Metformin DR plus metformin IR placebo)ExperimentalGroup A will receive 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2×placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).
Receives: Drug: Metformin DR; Drug: Metformin IR placebo
Placebo Arm (Metformin DR placebo plus metformin IR placebo)Placebo comparatorGroup B will receive placebo for 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2× placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).
Receives: Drug: Metformin DR Placebo; Drug: Metformin IR placebo
Active Control Arm (Metformin DR placebo plus metformin IR)Active comparatorGroup C will receive placebo for 1800 mg Metformin DR qAM + 1500 mg metformin IR in divided doses (2× metformin IR 500 mg qAM and 1× metformin IR 500 mg qPM).
Receives: Drug: Metformin IR; Drug: Metformin DR Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change in HbA1c in patients treated with Metformin DR compared to placebo

    Measured: Baseline to 28 weeks

Secondary outcomes (3)

  1. HbA1c response (Metformin DR vs. placebo)

    HbA1c absolute value-based response (Yes/No) at Week 28 defined as HbA1c ≤7% for Metformin DR compared to placebo

    Measured: Baseline to 28 weeks

  2. Change in HbA1c (Met DR vs. metformin IR)

    Change in HbA1c from the double-blind treatment period baseline to Week 28 for Metformin DR compared to Metformin IR

    Measured: Baseline to 28 weeks

  3. HbA1c response (Metformin DR vs. metformin IR)

    HbA1c absolute value-based response (Yes/No) at Week 28 defined as HbA1c ≤7% for Metformin DR compared to Metformin IR.

    Measured: Baseline to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start18 May 2021
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Why it stopped: Strategic company decision - not related to a safety concern

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
675 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04854512
Sponsor's protocol ID
ANJ900D3501
Acronym
DREAM-T2D
Status last verified
Mar 2023
First submitted
19 Apr 2021
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin DR and Metformin IR in people with Diabetes Mellitus, Type 2, run by Anji Pharma at 87 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Brazil, Poland, Canada, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Baseline to 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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