EUCTR2020-000763-23-HU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
适应症
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
- •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. 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 as applicable (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
- •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 (female patients) and testosterone (male patients)
- •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
排除标准
- •Exclusion Criteria:
- •1. Currently on dialysis, has been on any dialysis within 1 year of Visit 1B, 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 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)
- •5. Has a fasting lactate value > 2 mmol/L at Visit 1B
- •6. Has a bicarbonate value < 20 mEq/L at both Visit 1A and 1B
- •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 or Visit 3/3A, which can be rechecked within 1 week
- •9. Oral antidiabetic agent 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; inhaled, intranasal, ophthalmic, topical, or intra-articular corticosteroids are not exclusionary
- •c. 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
- •d. 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
- •e. Iodinated contrast dye within 1 week prior to Visit 3
- •f. Investigational drug within 8 weeks of the date of the first dose of randomized study medication
- •g. 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:
- •a. Hepatic disease
- •b. Gastrointestinal disease
- •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
- •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
- •13. 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 inve
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