CTRI/2025/06/089345尚未招募4 期
A Prospective, Multicentre, Single Arm, Open-Label, Phase IV Study to Assess Efficacy and Safety of Fixed Dose Combination of Dapagliflozin, Glimepiride and Extended Release Metformin Hydrochloride Tablets in Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 216
- 试验地点
- 14
- 主要终点
- Mean change in HbA1c from Baseline at the end of Week 16
研究概览
简要总结
This is a prospective, single-arm, multicentre, open-label, phase IV study. The study will be conducted at approximately 15-18 centres in India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
Screening Period
The screening period will be of 2 weeks. During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments (Appendix I). Patients will be provided with screening diary at screening visit to record concomitant medications and adverse events.
Treatment Period
After confirming eligibility, patients will be enrolled into treatment period. A total of 216 patients will be enrolled in the study. In this study, total treatment period will be of 28 weeks. This 28-week treatment period will be divided into 16 weeks of treatment period 1 and 12 weeks of treatment period 2.
Note: * If a patient is withdrawn or early terminated, EOT visit should be completed. Such patients will have safety at 2 weeks after EOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study at the time of screening.
- •Patients with diagnosis of type 2 diabetes mellitus.
- •Patients along with diet and exercise control, additionally on stable total daily dose of Glimepiride 1 mg and Metformin Sustained Release (SR)/Prolonged Release (PR)/Extended Release (greater than 500 mg to 1000 mg) OR on stable total daily dose Dapagliflozin 10 mg and Metformin SR/PR/Extended Release (greater than 500 mg to1000 mg) for at least 8 weeks prior to screening.
- •Patients with HbA1c greater than equal to 8.0% and less than or equal to 11% at screening and enrolment.
- •Patients with Body mass index (BMI) less than or equal to 45.0 kg/m2 at screening.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence).
排除标准
- •Patients diagnosed with type 1 diabetes, diabetes insipidus, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing syndrome or acromegaly-associated diabetes) 2) Patients with Fasting Blood Glucose (FBG) greater than or equal to 270 mg/dL at screening (if required, measurement can be repeated and confirmed within 7 days) and enrolment 3) Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes (e.g., sulfonamide) or to any of its excipients.
- •Patients with administration of any therapy for diabetes, other than Metformin and Glimepiride OR Metformin and Dapagliflozin during 8 weeks prior to screening.
- •Patients with history of taking any weight loss medications within 3 months prior to enrolment.
- •Patients planning to take any anti-diabetic drugs or weight loss drugs other than study drugs or rescue medication during the study.
- •Treatment with glucocorticoids equivalent to oral prednisolone greater than or equal to 10 mg (betamethasone greater than or equal to 1.2 mg, dexamethasone greater than or equal to 1.5 mg , hydrocortisone greater than or equal to 40 mg) per day within 30 days prior to Enrolment; topical, nasal or inhaled corticosteroids are allowed.
- •Patients having significant renal (estimated Glomerular Filtration Rate (eGFR) below 45 mL/min/1.73 m2) or hepatic impairment (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] greater than 3 times the upper limit of normal [ULN]) at Screening.
- •Patients having history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis, pancreatitis or hyperosmolar state (including coma).
- •Patients suffering from severe urinary tract infections (e.g, urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournier’s Gangrene), intravascular volume contraction and/or female genital mycotic infections prior to 6 months from screening.
- •Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack prior to 6 months from screening.
- •Patients with history of sustained and clinically relevant ventricular arrhythmia.
- •Any of the following electrocardiogram (ECG) abnormalities at screening: • Second- or third-degree atrioventricular block (AV) block without a pacemaker • Long QT syndrome or QTc greater than 500 ms.
- •Patients having history or currently suffering with serious allergic and hypersensitivity reactions such as anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and urticaria 16) Patients with any clinically significant laboratory abnormalities/condition (e.g. immunocompromised status, malignancy, hyperthyroidism etc.) which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
- •Patients are on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to screening.
- •Note: Patients who meet this criterion may be re-screened after being on a stable dose of thyroid.
- •Pregnant or lactating woman 20) Patients who has participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study.
结局指标
主要结局
Mean change in HbA1c from Baseline at the end of Week 16
时间窗: Baseline and end of Week 16
次要结局
- Mean change in HbA1c from Baseline at the end of Weeks 12 and 28(Baseline and end of Weeks 12 and 28)
- Mean change in PPBG, FBG from Baseline at the end of Weeks 12, 16 and 28(Baseline and end of Weeks 12, 16 and 28)
- Proportion of patients achieving HbA1c less than 7.0% at the end of Weeks 12, 16 and 28(At the end of Weeks 12, 16 and 28)
- Mean change in bodyweight from Baseline to end of Weeks 12, 16 and 28(Baseline and end of Weeks 12, 16 and 28)
- Proportion of patients receiving rescue medications by Weeks 12, 16 and 28(Weeks 12, 16 and 28)
研究者
研究点 (14)
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