A clinical study to assess the efficacy and safety of combination of Vildagliptin plus Pioglitazone Tablets in patients with diabetes.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2022/09/045148
- Lead Sponsor
- Synokem Pharmaceuticals Ltd
- Brief Summary
Thistrial is a phase III, prospective, randomized, double blind, comparative,parallel group, multicenter clinical study to evaluate the efficacy, safety andtolerability of FDC of Vildagliptin SR 100 mg + Pioglitazone 15 mg Tabletsversus FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets in patients withtype 2 diabetes mellitus inadequately controlled on Metformin monotherapy.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening / baseline visit (Visit 1).During this screening period, patients who are willing to give consent will beevaluated for all the eligibility criteria. Eligible patients (male or female) agedbetween 18 to 65 years (both inclusive), who are on the treatment with Metformin Tablets ≥1500 mg/day for at least 3months prior to screening and having inadequate glycaemic control [GlycosylatedHaemoglobin (HbA1c) levels of ≥ 8.0% to ≤ 11.0%] will be considered for the study.
After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with diary at randomization visit, which needto be brought along with in each subsequent visit till the last visit. Followup visits will be done on week 2/day 14(±3), week 6/day 42(±3), week 12/day84(±3) and week 16/day 112(±3) (Final Visit) of treatment to assess efficacy, safetyand tolerability.
Patientswill be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDCof Vildagliptin SR 100 mg + Pioglitazone 15 mg Tablets or FDC of Teneligliptin20 mg + Pioglitazone 15 mg Tablets. Patients will be given the study medicationonce daily for 16 weeks. In addition, subjects will continue to receiveMetformin at stable doses of ≥1500mg/day, throughout the study period in an open label manner (16 weeks).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 172
- Male or Female Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus.
- Patients who have received stable dose of Metformin ≥ 1500 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 8.0% to ≤ 11.0%.
- 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.
- Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- Patients with a history of metabolic acidosis or diabetic ketoacidosis.
- Patients with a history of bariatric surgery or lap-band procedure within 12 months prior to screening.
- Patients with Fasting Plasma Glucose (FPG) > 270 mg/dL at screening (If FPG is > 270 mg/dL at screening, FPG will be repeated within 1 week.
- If repeat FPG is > 270 mg/dL, patient will be excluded from the study).
- Patients with the Body Mass Index (BMI) ≥ 45.0 kg/m2 at screening.
- Patients with Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [using the Modification of Diet in Renal Disease (MDRD) equation] at screening.
- Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL) at screening.
- Patients with a history of congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
- 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.
- Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
- Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- Patients with history of hereditary QT prolongation syndrome or patients having history of Torsades de pointes.
- Patients who are accepting treatments of arrhythmias.
- Patients with known history of acute pancreatitis.
- Patients with a history of treatment with estrogens and other medications known to affect bone.
- Patients with history of clinically significant peripheral edema in past 6 months.
- Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other DPP4 inhibitors or thiazolidinediones.
- Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- Patients with history of any malignancy.
- 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 30 days prior to signing informed consent.
- Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- Suspected inability or unwillingness to comply with the study procedures.
- 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 (16 weeks). At Screening / baseline visit, | Visit 5 (Week 12 / Day 84±2) and | Visit 6 (Week 16 / Day 112±2).
- Secondary Outcome Measures
Name Time Method Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (16 weeks). At Screening / baseline visit, Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (16 weeks). At Screening / baseline visit, Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (16 weeks). At Visit 6 (Week 16 / Day 112±2). Mean change in body weight from baseline to end of the study visit (16 weeks). At Screening / baseline visit, Hypoglycemic episodes during the study During the treatment period. Adverse events / serious adverse events reported during the study. Changes in clinical laboratory parameters from baseline to end of the study visit (16 weeks). At Screening / baseline visit and
Trial Locations
- Locations (10)
Aatman Hospital
🇮🇳Ahmadabad, GUJARAT, India
Calcutta School of Tropical Medicine
🇮🇳Kolkata, WEST BENGAL, India
Gandhi Medical College and Hospital
🇮🇳Hyderabad, TELANGANA, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Jawahar Lal Nehru (J.L.N) Medical College
🇮🇳Ajmer, RAJASTHAN, India
Maharaja Agrasen Superspeciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
Medical College and Hospital, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital
🇮🇳Kolhapur, MAHARASHTRA, India
Redkar Hospital and Research Centre
🇮🇳Goa, GOA, India
W Pratiksha Hospital
🇮🇳Gurgaon, HARYANA, India
Aatman Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Chintan B PatelPrincipal investigator9825182251cr.aatman@gmail.com