A clinical study to assess the efficacy and safety of Linagliptin plus Glimepiride Tablets in patients with diabetes.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2023/04/051711
- Lead Sponsor
- Exemed Pharmaceuticals
- Brief Summary
Thistrial is a phase III, randomized, double blind, active controlled, prospective,parallel group, comparative, multicentric clinical study to evaluate theefficacy, safety and tolerability of fixed dose combination of Linagliptin plusGlimepiride Tablets versus Linagliptin Tablets 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), along with diet and exercise control,additionally on stable total daily dose of Metformin Hydrochloride ≥ 1500 mgfor at least 8 weeks prior to screening and glycosylated hemoglobin (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 patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on week 2/day 14(±3), week 6/day 42(±3), week12/day 84(±3) and week 16/day 112(±3) (Final Visit) of treatment to assess efficacyand safety.
Patients will be assigned to either of the three armsi.e., Arm A or Arm B or Arm C consisting of FDC of Linagliptin 5 mg +Glimepiride 1 mg Tablets or FDC of Linagliptin 5 mg + Glimepiride 2 mg Tabletsor Linagliptin Tablets 5 mg. Metformin Tablets ≥ 1500 mg/day will be continued throughout thestudy period (16 weeks).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 258
- Male or female patients aged between 18 to 65 years (both inclusive) with diagnosis of type 2 diabetes mellitus.
- Patients, along with diet and exercise control, additionally on stable total daily dose of Metformin Hydrochloride ≥ 1500 mg for at least 8 weeks prior to screening.
- Patients having inadequate glycemic control defined as glycosylated hemoglobin (HbA1c) levels of ≥ 8.0% to ≤ 11.0% at screening visit.
- 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) > 270 mg/dL at screening.
- 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 ULN and/or Total bilirubin more than 1.5X the ULN) 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 history of sustained and clinically relevant ventricular arrhythmia.
- Patients with history or currently suffering with bullous pemphigoid requiring hospitalization and taking DPP-4 inhibitors.
- Patients with history of inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption.
- Patients with any condition (e.g., infection, trauma and surgery) which require insulin therapy at the time of screening or during the study period.
- 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 who are accepting treatments of arrhythmias.
- Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin < 10 g/dL for men; haemoglobin < 9 g/dL for women at screening.
- Patients with intolerance, contraindication or potential allergy/hypersensitivity to DPP4 inhibitors.
- Female patients who are 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 donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
- 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 haemoglobin (HbA1c) from baseline to end of the study visit (week 16). At Screening or baseline visit (Visit 1), | Visit 5 [Week 12/Day 84(±3)] and | Visit 6 [Week 16/Day 112(±3)].
- Secondary Outcome Measures
Name Time Method Number of patients requiring hypoglycemia management during the study. At Visit 3 [Week 2/Day 14(±3)], Changes in clinical laboratory parameters from baseline to end of the study visit (week 16). At Screening or baseline visit (Visit 1) and Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 16). At Screening or baseline visit (Visit 1), Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 16). At Screening or baseline visit (Visit 1), Proportion of patients achieving a therapeutic glycemic response, defined as HbA1c 7% at the end of the study visit (week 16). At Visit 6 [Week 16/Day112 (±3)]. Number of patients requiring rescue medications during the study. At Visit 3 [Week 2/Day 14(±3)], Hypoglycemic episodes during the study. Throughout the study. Mean change in body weight from baseline to end of the study visit (week 16). At Screening or baseline visit (Visit 1), Adverse events / serious adverse events reported during the study. Throughout the study.
Trial Locations
- Locations (13)
Aatman Hospital
🇮🇳Ahmadabad, GUJARAT, India
Calcutta School of Tropical Medicine
🇮🇳Kolkata, WEST BENGAL, India
Chandani Hospital Pvt. Ltd.
🇮🇳Nagar, UTTAR PRADESH, India
College of Medicine & Sagore Dutta Hospital
🇮🇳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
Scroll for more (3 remaining)Aatman Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Chintan B PatelPrincipal investigator9825182251cr.aatman@gmail.com