Investigational Study of Delayed Release Metformin (DREAM-T2D)

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Investigational Study of Delayed Release Metformin (DREAM-T2D)

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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


Inclusion Criteria
  1. Is male or female and at least 18 years old
  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
  5. Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation
  6. Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks
  7. If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks
    • 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
Exclusion Criteria
  1. Is currently on dialysis, has been on any dialysis within 1 year, or is expected to undergo dialysis during the study period
  2. Has a history of lactic acidosis
  3. Has a fasting plasma glucose (FPG) value >240 mg/dL (>13.3 mmol/L)
  4. An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN (except in case of documented Gilbert’s syndrome)
  5. Has a fasting plasma lactate value >2 mol
  6. Has a bicarbonate value ≤20 mEq/L.
  7. A history of >5% weight change within 12 weeks
  8. Has mean BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP)
  9. Oral antidiabetic agent or insulin use that is not stable for 8 weeks (i.e., change in oral medication dose or basal insulin dose increased or decreased by more than 20% during the 8 weeks)
  10. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
  11. 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; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary
    • Planned use of proton pump inhibitors after Visit 2; 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, 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)
    • Iodinated contrast dye within 1 week prior to Visit 3
    • Investigational drug within 8 weeks (or 5 half-lives of the investigational drug, whichever is greater)
    • Metformin DR or double-blind matching placebo for Metformin DR at any time prior to the study
    • 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; Prior or expected surgical gastrointestinal procedure that may impact the gut hormonal response to study medical such as gastric bypass surgery or gastric banding surgery; Active diagnosis of Pancreatitis
    • Endocrine disorder other than T2DM or hypothyroidism on replacement therapy
    • Cardiovascular disease, including history of stroke, decompensated heart failure NYHA Class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty within 3 months
    • Central nervous system diseases such as epislepsy
    • Psychiatric or neurological disorders that in the Investigator’s opinion would cause the patient to be noncompliant with study procedures
    • Organ transplantation
    • Chronic or acute infection requiring systemic antibiotic treatment
    • Orthostatic hypotension or syncope
    • 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
  14. A physical, psychological, or historical finding that would make the patient unsuitable for the study
  15. Currently abuses drugs or alcohol or has a known history of abuse
  16. Had a blood transfusion or experienced significant blood loss (i.e., >500 mL), including loss due to blood donation, within 8 weeks, or is planning to donate blood or have a blood transfusion during the study
  17. Prior or planned major surgery of any kind (requiring overnight hospitalization) within 6 months of Visit 1B
  18. Patients insufficiently compliant with study medication during the placebo run-in phase (<85% or >115%) as assessed at Visit 4
  19. Is screening for the study at more than one clinical site or is participating in any other clinical study
  20. Is currently pregnant or breastfeeding or plans to become pregnant during the course of the study
  21. 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
  22. 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
  23. Is employed by Anji Pharma (that is an employee, contract worker, or designee of the company).
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