A Phase 3 study will assess the efficacy, safety, and tolerability of a fixed-dose combination (FDC) of dapagliflozin 10mg and pioglitazone 15mg tablets versus separate doses of Forxiga 10mg and Pioglit® 15mg in Type 2 diabetes patients inadequately controlled on metformin monotherapy.
Phase 3
Recruiting
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2024/09/073221
- Lead Sponsor
- USV Pvt Ltd
- Brief Summary
**A PhaseIII, Prospective, Randomized, Open Label, ActiveControlled, Parallel Group,Multicenter Clinical Study**
**Test Product:** Fixed Dose Combination ofDapagliflozin and pioglitazone Tablets 10mg/15mg of USV Private Limited., Indiaadministered in morning (OD).
**ReferenceProducts:** Concomitantadministration of Forxiga 10 mg (Dapagliflozin)tablets of AstraZeneca Pharma India limited and Pioglit® 15mg (Pioglitazone) tablets, of Sunpharma Laboratories Pharmaceuticals, administeredin morning (OD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- 1.Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus. 2.Patients who have ongoing mono therapy.
- to be enrolled and continue them with dual therapy. i.e Patients with HbA1C level ≥ 7.5% to 10%.and who are presently on ≥1000 mg/day Metformin for at least 3 months prior to screening 3.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. 4.Patients with no abnormality on 12-lead ECG at screening / baseline visit. 5.Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6.Patients willing to comply with the protocol requirements.
Exclusion Criteria
- 1.Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- 2.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 3.Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- 4.Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening 5.Patients with Fasting Plasma Glucose (FPG) > 240 mg/dL at screening or randomization 6.Patients with Estimated glomerular filtration rate (eGFR) <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.
- 7.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.
- 8.Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 or DPP4 inhibitors 9.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 10.Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
- 11.Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
- 12.Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- 13.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.
- 14.Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- 15.Suspected inability or unwillingness to comply with the study procedures.
- 16.Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in glycosylated hemoglobin (HbA1c) from baseline to end of the study visit (12 Weeks). Screening/Baseline Visit [V1](Day -7) Randomization visit [V2] (Day1) Follow up visit [V3] Week 2 / Day 14(±2) Follow up visit [V4] Week 6 / Day 42(±2) Final Visit[V5] | Week 12/Day 84 (±2)
- Secondary Outcome Measures
Name Time Method â—Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (12 Weeks). â—Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (12 Weeks).
Trial Locations
- Locations (16)
All India Institute of Medical Sciences Hospital
🇮🇳Nagpur, MAHARASHTRA, India
AMRI Hospital
🇮🇳Khordha, ORISSA, India
College of Medicine and JNM Hospital
🇮🇳Nadia, WEST BENGAL, India
Cresent Hospital and Heart Center
🇮🇳Nagpur, MAHARASHTRA, India
Dr B L Kapur Memorial Hospital
🇮🇳Delhi, DELHI, India
Goroshi Clinic
🇮🇳Belgaum, KARNATAKA, India
Jupiter Hospital
🇮🇳Vadodara, GUJARAT, India
Medstar Speciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Metri Clinic
🇮🇳Belgaum, KARNATAKA, India
Poona Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Scroll for more (6 remaining)All India Institute of Medical Sciences Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDr Keshao B NagpurePrincipal investigator9822086848kartikmed@rediffmail.com