EUCTR2020-000763-23-BG进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 371
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
排除标准
- •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
- •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
- •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
- 另有 11 项未显示
研究者
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