A Phase III, Prospective, Randomized, Open Label, Active Controlled, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination of Dapagliflozin and Pioglitazone Tablets 10mg and 15mg of Eris Lifesciences Limited, India as compared to Concomitant Administration of Reference Product Forxiga 10 mg of AstraZeneca Pharma India limited., along with Pioglit® 15 mg tablets of Sun Pharma Laboratories India Ltd, in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on earlier metformin containing monotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 试验地点
- 12
- 主要终点
- Evaluate mean change in HbA1c levels from baseline compared to end of study visit-week 16
研究概览
简要总结
After informed consent process, completion of all screening assessments and once all the inclusion-exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history will be recorded at screening visit. Details of concomitant medications and adverse events if any shall be recorded during each visit. Prior medication will be recorded during screening visit. Physical examination (including general and systemic examinations) shall be done during screening and each successive visit. Vital signs (like blood pressure, pulse rate, respiratory rate, and body temperature) shall be measured on each visit. Measurement of Body weight and BMI calculation will be performed at each visit. Urine pregnancy test for females of childbearing potential shall be performed during screening visit and end of study visit. Laboratory assessments (Haematology and Biochemistry) shall be performed on screening and end of study visit.
eGFR will be performed at screening and end of study visit. Urine Analysis (Routine & Microscopic) and serum electrolytes shall be performed during each visit except baseline visit. 12-Lead ECG examinations shall be performed during screening and end of study visit. HbA1c levels shall be performed at screening and end of study visit. TSH, T3, T4 tests will be performed at screening visit. FPG and PPBG levels shall be performed at each successive visit. Serum amylase and lipase test will be performed at screening and end of study visit. Patients will be provided with glucometer and subject diary to record details about study drug administration, rescue medication, adverse events, and hypoglycemia events. Glucometer will be provided to patients to self-monitor their blood glucose level twice weekly (should be at least 3 days apart) and the readings will be recorded in patient diary. Patients will be instructed to fast for ≥ 12 hours prior to their visit. Patients will be required to bring completed diary and glucometer at each visit.
Diet and lifestyle modification counselling will be given to the patients and the same shall be reinforced during the study. Patients will be instructed to administer one tablet of test product or comparator product once daily in the morning with food for 12 weeks of treatment duration. Note. Stable dose of Metformin (whichever patients using prior to screening visit) should continue throughout the study. Patients shall complete seven scheduled clinic visits as follows. Visit 1. Screening Visit (Days -7 to Day 0) Visit 2. Randomization-Baseline Visit (Day 0) Visit 3. Interim Visit (Week 2-Day 14 ±3 days) Visit 4. Interim Visit (Week 4-Day 28 ± 3 days) Visit 5. Interim Visit (Week 8-Day 56 ± 3 days) Visit 5. End of Study-Early Discontinuation Visit (Week 12-Day 84 ± 3 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female Patients aged between 18 to 65 both inclusive years with diagnosis of Type 2 diabetes mellitus.
- •Patients who have ongoing mono therapy.
- •to be enrolled and continue them with dual therapy.i.e Patients with HbA1C level greater than or equal to 7.5% to 10% and who are presently on greater than or equal to 1000 mg-day Metformin for at least 3 months prior to screening
- •Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening.
- •baseline visit.
- •Patients with no abnormality on 12-lead ECG at screening.
- •baseline visit.
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening
- •Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- •Patients with the Body Mass Index (BMI) greater than or equal to 45.0 kg-m2 at screening
- •Patients with Fasting Plasma Glucose (FPG) greater-than 240 mg-dL at screening or randomization
- •Patients with Estimated glomerular filtration rate (eGFR) less-than sign 60 mL-min-1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] or serum creatinine level of 1.5 mg dL for male subjects and 1.4 mg-dL for female subjects at screening.
- •Patients with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
- •Intolerance, contraindication or potential allergy-hypersensitivity to any of the ingredients of study medication or any other SGLT2 or DPP4 inhibitors
- •Laboratory findings measured at screening: a) Neutrophils less-than sign 2000 mm3 b) Platelets less-than sign100,000 mm3 c) Total bilirubin greater-than 1.5 X ULN d) ALT- AST greater-than 2.5 X ULN e) Serum amylase and-or lipase greater-than 3 X ULN f) Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study.
- •Patients with a history of anaemia or haemoglobinopathy and-or haemoglobin less-than sign 10 g dL for men; haemoglobin less-than sign 9 g dL for women at screening.
- •Patients with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and-or diastolic BP greater than or equal to 100 mmHg at screening.
- •Patients with known case of infection with hepatitis B, hepatitis C or HIV
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
Evaluate mean change in HbA1c levels from baseline compared to end of study visit-week 16
时间窗: Below mentioned visit and times lines | Visit 1. Screening Visit Days -7 to Day 0 | Visit 2. Randomization-Baseline Visit Day 0 | Visit 3. Interim Visit Week 2Day 14 ± 3 days | Visit 4. Interim Visit Week 4-Day 28 ± 3 days | Visit 5. Interim Visit Week 8-Day 56 ± 3 days | Visit 6. End of Study-Early Discontinuation Visit Week 12-Day 84 ± 3 days
次要结局
- Evaluate mean change in Fasting Plasma Glucos levels from baseline at the end of Week 2, 4, 8, and 12.(Evaluate mean change in 2-hour post prandial blood glucose levels from baseline at the end of Week 2, 4, 8, and 12.)
研究者
Mr Ganesh Boddu
Eris Lifesciences Ltd