Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: FDC of Dapagliflozin 10 mg + Metformin 500 mg +
Vildagliptin 100 mg (SR): 1 tablet in a day for 6 months
Control Intervention1: FDC of Dapagliflozin 10mg + Metformin 500mg: 1 tablet in
Sponsors
USV Private Limited
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject willing to provide written informed consent. 2.Subject having documented history of diabetes mellitus greater than or equal to 12 months 3.Subjects receiving 2 or more Oral anti-hyperglycaemic medications (OAMs) at stable doses for 12 weeks prior to screening, with metformin greater than or equal 500 mg per day or dapagliflozin ( greater than or equal 5 mg/day) or vildagliptin (greater than or equal 100 mg/day) 4.Glycated haemoglobin (HbA1c) between 8.0% and 10.5%. 5.Subjects with body mass index (BMI) Greater than 18 kg/m and less than 40 kg/m at screening 6.Ability and willingness to administer study medication as prescribed by the study investigator 7.As determined by the investigator, the subject should be capable and willing to do the following: a.Perform self-monitored blood glucose (SMBG) at least once weekly and at the occurrence of hypoglycaemia symptoms b.Complete subject diaries as instructed c.Be receptive to diabetes education
Exclusion criteria
Exclusion criteria: 1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation 2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with the test product to be used 3.Female subject who is pregnant or lactating 4.Subjects with a diagnosis of type 1 diabetes, gestational diabetes mellitus 5.Subject with abnormal eGFR (less than 30 mL per min or 1.73 m2). 6.Subjects with any one of the following comorbid conditions physical or mental retardation, or malignancy 7.Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse 8.Not eligible to participate in this trial based on investigator opinion 9.Trial related conditions a.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent b.Suspected inability or unwillingness to comply with the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in demographic characteristics, clinical parameters and treatment patternTimepoint: From baseline to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluates the safety of patientsTimepoint: Safety will be evaluated at various time points of the study at 3 months & 6 months | — |
Countries
India
Contacts
Public ContactDr Sona Warrier
USV Private Limited
Outcome results
None listed