A clinical trial to study the efficacy and safety of fixed dose combination of Teneligliptin and Pioglitazone in the treatment of type 2 diabetes mellitus.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2020/10/028319
- 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 Teneligliptin 20 mg + Pioglitazone 15 mg Tablets and FDCof Teneligliptin 20 mg + Pioglitazone 30 mg Tablets versus TeneligliptinTablets 20 mg and Pioglitazone Tablets 30 mg in patients with type 2 diabetesmellitus 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 ≥1000 mg/day for at least 3 months prior to screening and havinginadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of ≥ 7%to ≤ 10%] will be considered for the study.
Patientswill be assigned to either of the four arms i.e. Arm A or Arm B or Arm C or ArmD consisting of FDC of Teneligliptin 20 mg + Pioglitazone 15 mg Tablets or FDCof Teneligliptin 20 mg + Pioglitazone 30 mg Tablets or Teneligliptin Tablets 20mg or Pioglitazone Tablets 30 mg. Patients will be given the study medicationonce daily for 24 weeks. In addition, subjects will continue to receiveMetformin at stable doses of ≥1000mg/day, throughout the study period in an open label manner (24 weeks).
After confirmingthe inclusion/exclusion criteria the subject will be randomized and providedwith study medication at randomization visit. Subjects will be provided with diaryat randomization visit, which need to be brought along with in each subsequentvisit till the last visit. Follow up visits will be done on week 2/day 14(±2),week 6/day 42(±2), week 12/day 84(±2), week 18/day 126(±2) and week 24/day168(±2) (Final Visit) of treatment to assess efficacy, safety and tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 328
- 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 ≥ 1000 mg/day as monotherapy for at least 3 months prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 7% to ≤ 10%.
- 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 Fasting Plasma Glucose (FPG) > 220 mg/dL at screening (If FPG is > 220 mg/dL at screening, FPG will be repeated within 1 week.
- If repeat FPG is > 220 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 2.5X 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.
- For male patients with mean QTcB ≥ 450 msec or female patients with mean QTcB ≥ 470 msec, triplicate ECG will be performed.
- If mean QTcB is ≥ 450 msec in males or mean QTcB is ≥ 470 msec in females on triplicate ECG, patient will be excluded from 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 90 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 (24 weeks). Baseline, Week 12 and Week 24
- Secondary Outcome Measures
Name Time Method Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (24 weeks). Baseline, Week 2, Week 6, Week 12, Week 18 and Week 24 Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (24 weeks). Baseline, Week 2, Week 6, Week 12, Week 18 and Week 24 Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (24 weeks). Week 24
Trial Locations
- Locations (16)
Anu Hospitals
🇮🇳Krishna, ANDHRA PRADESH, India
Apex Hospitals Private Limited
🇮🇳Jaipur, RAJASTHAN, India
Calcutta School of Tropical Medicine
🇮🇳Kolkata, WEST BENGAL, India
Chirayu Hospital
🇮🇳Jaipur, RAJASTHAN, India
Down Town Hospital
🇮🇳Kamrup, ASSAM, India
Gandhi Medical College / Hospital
🇮🇳Hyderabad, TELANGANA, India
Government Medical College & Government General Hospital (Old RIMSGGH)
🇮🇳Srikakulam, ANDHRA PRADESH, 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
Scroll for more (6 remaining)Anu Hospitals🇮🇳Krishna, ANDHRA PRADESH, IndiaDr S Poorna Gopal AzadPrincipal investigator7794022370drcresearch@gmail.com