EUCTR2020-000763-23-PLActive, not recruitingPhase 1
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo- and Comparator-Controlled Study to Compare the Glycemic Effects, Safety, and Tolerability of Metformin Hydrochloride Delayed-Release Tablets in Patients with Type 2 Diabetes Mellitus with varying renal function from normal up to CKD3B
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Anji Pharma (US) LLC
- Enrollment
- 675
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Note: Patients not eligible because of laboratory result(s) or blood pressure (BP) or electrocardiogram (ECG) assessments or weight being slightly over or under the required body mass index (BMI) may have these assessments repeated once during the screening period at the discretion of the investigator to determine eligibility.
- •Each patient must meet the following criteria to be enrolled in this study:
- •1. Adult at least 18 years old
- •2. Has BMI 20.0 to 45.0 kg/m2 (inclusive)
- •3. Has T2DM
- •4. For patients on metformin at screening: 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). For patients with CKD3B not on metformin at screening: HbA1c of 7.0% to 10.5%, inclusive, at Visit 1A and at Week -2 (Visit 1B/3)
- •5. For patients on metformin at screening: eGFR value of =30 mL/min/1.73 m2 based on the CKD-EPI equation at Visits 1A and 3/3A (Week -2). For patients with CKD3B not on metformin at screening: eGFR value of 30 to 44 mL/min/1.73 m2 based on the CKD-EPI equation at Visits 1A and 1B/3 (Week -2)
- •6. For patients on metformin at screening: 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 or 1B/3
- •a. Drugs known to affect body weight, including prescription medications (e.g.,phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone, high dose GLP-1 agonists) and over-the-counter anti-obesity agents
- •b. Hormone replacement therapy estrogen or testosterone
- •c. Oral contraceptives (female patients)
- •d. Antihypertensive agents including ACEi/ARB
- •e. Lipid-lowering agents
- •f. Thyroid replacement therapy
- •g. Antidepressant agents
- •8. Ability to understand and willingness to adhere to protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
Exclusion Criteria
- •1. Currently on dialysis,has been on any dialysis within 1 year of Visit 1B or 1B/3, or is expected to undergo dialysis during the study
- •2. Has a history of lactic acidosis
- •3. Has a FPG value >240 mg/dL (>13.3 mmol/L) at Week -2 (Visit 3/3A or 1B/3 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, 3/3A, or 1B/3 (except in case of documented Gilbert’s syndrome)
- •5. Has a fasting lactate value > 3 mmol/L at Visit 1B or 1B/3
- •6. Has a bicarbonate value <18 mEq/L at both Visits 1A and 1B or Visits 1A and 1B/3
- •7. History of >5% weight change within 12 weeks prior to Visit 1A
- •8. BP measurements >180 mmHg (systolic BP) or >100 mmHg (diastolic BP) at Visit 1A, 3/3A or 1B/3, which can be rechecked within 1 week
- •9. Oral antidiabetic agent,GLP-1 agonist or insulin use that is not stable for 6 weeks prior to randomization
- •10. Has been treated,is currently being treated,or is expected to require or undergo treatment with any of the following excluded medications:
- •a. Prescribed metformin preparation after initiation of metformin washout following Visit 1B
- •b. Greater than 10 consecutive days of systemic corticosteroids by oral, intravenous, or intramuscular route within 12 weeks of Visit 1B or 1B/3; inhaled,intranasal,ophthalmic,topical or intra-articular corticosteroids are not exclusionary
- •c. Planned use of proton pump inhibitors after Visit 2 (for those patients who undergo
- •metformin washout) or 1B/3 (for patients with CKD3B not on metformin); such use could potentially affect the DR and PK of Metformin DR.
- •d. Cationic drugs that are eliminated by renal tubular secretion 1 week prior to Visit 3 or 1B/3 onwards,unless treatment is in accordance with the product label for the patient’s renal function.
- •e. Iodinated contrast dye 1 week prior to Visit 3 or 1B/3 onwards
- •f. Investigational drug within 8 weeks of the date of the first dose prior to randomized study medication
- •g. Metformin DR or double-blind matching placebo for Metformin DR at any time prior to Visit 1B or 1B/3
- •h. Nephrotoxic medications and medications that are known to impact eGFR
- •11. Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being
- •12. Known allergy or hypersensitivity to Metformin DR, Metformin IR,or placebo or any inactive component of study medication,active comparator,or placebo
- •13. History of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within 1 year prior to Visit 1B or 1B/3
- •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 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 1B/3, or is planning to donate blood or have a blood transfusion during the study
- •18. Prior or planned major surge
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