Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
675 participants
INTERVENTIONAL
2021-05-18
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Investigational Arm (Metformin DR plus metformin IR placebo)
Group 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).
Metformin DR
Delay-Release Metformin
Metformin IR placebo
Metformin IR placebo
Placebo Arm (Metformin DR placebo plus metformin IR placebo)
Group 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).
Metformin DR Placebo
Metformin DR Placebo
Metformin IR placebo
Metformin IR placebo
Active Control Arm (Metformin DR placebo plus metformin IR)
Group 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).
Metformin IR
Immediate Release Metformin
Metformin DR Placebo
Metformin DR Placebo
Interventions
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Metformin DR
Delay-Release Metformin
Metformin IR
Immediate Release Metformin
Metformin DR Placebo
Metformin DR Placebo
Metformin IR placebo
Metformin IR placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has body mass index 20.0 to 45.0 kg/m2 (inclusive)
3. Has T2DM
4. 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)
5. 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)
6. Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A
7. If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B
1. 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
2. Hormone replacement therapy (female patients) and testosterone (male patients)
3. Oral contraceptives (female patients)
4. Antihypertensive agents including ACEi/ARB
5. Lipid-lowering agents
6. Thyroid replacement therapy
7. Antidepressant agents
8. Ability to understand and willingness to adhere to protocol requirements
Exclusion Criteria
2. Has a history of lactic acidosis
3. Has a fasting plasma glucose (FPG) value \>240 mg/dL (\>13.3 mmol/L) at Week -2 (Visit 3/3A as applicable)
4. 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)
5. Has a fasting plasma lactate value \>2 mol at Visit 1B
6. 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
7. A history of \>5% weight change within 12 weeks prior to Visit 1A
8. 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)
9. 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 \[Day 1\])
10. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
1. Prescribed metformin preparation after initiation of metformin washout following Visit 1B
2. 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
3. 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
4. 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)
5. Iodinated contrast dye within 1 week prior to Visit 3 (Week -2)
6. 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
7. Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B
11. 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:
1. Hepatic disease
2. Gastrointestinal disease, including but not limited to:
i. 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
12. 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)
13. Has a history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B
14. A physical, psychological, or historical finding that, in the Investigator's opinion, would make the patient unsuitable for the study
15. 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
16. 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
17. 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
18. Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B
19. Patients insufficiently compliant with study medication during the placebo run-in phase (\<85% or \>115%) as assessed at Visit 4
20. Is screening for the study at more than one clinical site or is participating in any other clinical study
21. Is currently pregnant (confirmed by serum pregnancy test at Visit 1B) or breastfeeding or plans to become pregnant during the course of the study
22. 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
23. 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
24. Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company).
18 Years
100 Years
ALL
No
Sponsors
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Anji Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Meyers, MD
Role: STUDY_CHAIR
Chief Medical Officer - Anji Pharma
Locations
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Lenzmeier Family Medicine/CCT Research
Glendale, Arizona, United States
Aventiv Research
Mesa, Arizona, United States
Kidney & Hypertension Center / DaVita Clinical Research
Apple Valley, California, United States
California Institute of Renal Research
Chula Vista, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Valley Renal Medical Group Research
Northridge, California, United States
San Fernando Valley Health Institute
Van Nuys, California, United States
AGA Clinical Trials
Hialeah, Florida, United States
East Coast Institutue for Research
Jacksonville, Florida, United States
East Coast Institute for Research, LLC
Lake City, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Metabolic Research Institute, Inc
West Palm Beach, Florida, United States
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States
In-Quest Medical Research - Peachtree
Peachtree Corners, Georgia, United States
Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC)
Louisville, Kentucky, United States
Methodist Physicians Clinic / CCT Research
Fremont, Nebraska, United States
Midwest Regional Health Services
Omaha, Nebraska, United States
DaVita Clinical Research
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Lucas Research
Morehead City, North Carolina, United States
Eastern Nephrology Associates
New Bern, North Carolina, United States
Family Medicine of SayeBrook
Myrtle Beach, South Carolina, United States
South Carolina Clinical Research LLC
Orangeburg, South Carolina, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Office of Osvaldo A Brusco, MD
Corpus Christi, Texas, United States
Galenos Research
Dallas, Texas, United States
Endocrine IPS, PLLC
Houston, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
IACT Health
Suffolk, Virginia, United States
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, Ceará, Brazil
Centro de Pesquisas em Diabetes e Doencas Endrocrino-Metabolica Ltda
Fortaleza, Ceará, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Cline Research Center
Curitiba, Paraná, Brazil
Universidade Federal Do Para (UFPA) - Insitituto de Ciencas de Saude (ICS)
Belém, Pará, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Centro de Pesquisas em Diabetes Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Loema - Instituto de Pesquisa Clinica
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica de Campinas
Campinas, São Paulo, Brazil
ASOMC Endocrinology and Metabolic Diseases
Rousse, , Bulgaria
Medical Cetner Teodora
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment
Smolyan, , Bulgaria
Fourth Multipfoile Hospital for Active Treatment
Sofia, , Bulgaria
Medical Center New Rehabilition Cetner EOOD
Stara Zagora, , Bulgaria
Diagnostic Culsultative Cetner "Equita" EOOD
Varna, , Bulgaria
Medical Center Leo Clinical EOOD
Varna, , Bulgaria
BC Diabetes
Vancouver, British Columbia, Canada
LMC Manna Research (Barrie)
Barrie, Ontario, Canada
LMC Manna Research (Brampton)
Brampton, Ontario, Canada
Stephen S. Chow Medicine Professional Corporation
East York, Ontario, Canada
LMC Manna Research (Etobicoke)
Etobicoke, Ontario, Canada
LMC Manna Research (Ottawa)
Nepean, Ontario, Canada
LMC Manna Research (Bayview)
Toronto, Ontario, Canada
LMC Manna Research (Montreal)
Montreal, Quebec, Canada
Diahaza s.r.o.
Holešov, , Czechia
Diabetologicka ambulance
Krnov, , Czechia
Interni Ambulance
Olomouc, , Czechia
Endodiab s.r.o.
Prague, , Czechia
Diabet2 s.r.o.
Prague, , Czechia
Diabetologicka a podiatricka ambulance, Milan Kvapil s.r.o.
Prague, , Czechia
ResTrial s.r.o.
Prague, , Czechia
Borbanya Praxis EU Kft
Nyíregyháza, SZ, Hungary
Lausmed Kft
Baja, , Hungary
Principal SMO Ltd
Baja, , Hungary
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Bajscy-Zsilinszky Hospital
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyl Koxpont
Budapest, , Hungary
Borbanya Praxis EU k ft
Debrecen, , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, Poland
NZOZ NEUROMED M.iM. Nastaj Sp.P.
Lublin, Lublin Voivodeship, Poland
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Bialystok, , Poland
Centrum Medyczne Pratia
Katowice, , Poland
Pro Familia Altera Sp. z.o.o.
Katowice, , Poland
Diamond Medical Center
Krakow, , Poland
NBR Polska
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, , Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
Wroclaw, , Poland
Hospital Universitario Virgen del Rocio
Seville, SE, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, , Spain
Hospital Vithas Sevilla
Seville, , Spain
Countries
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Other Identifiers
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ANJ900D3501
Identifier Type: -
Identifier Source: org_study_id
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