Health Condition 1: E110- Type 2 diabetes mellitus with hyperosmolarity
Conditions
Interventions
Intervention1: FDC of Dapagliflozin 10mg, and Gliclazide 60 mg SR tablet.: Patient will be asked to consume one tablet of FDC of Dapagliflozin 10mg, and Gliclazide 60 mg SR tablets) once daily in the
Sponsors
Eris Life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing to give written informed consent to participate 2.Both genders (Male and Female) Age: 18-65 years both inclusive 3.Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test. 4.BMI: 5.HbA1c: =8.0% to =10.0% 6.In Patients with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin Monotherapy =1000 mg per day for at least 3 months and having inadequate glycemic control 7.Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.History of unstable or rapidly progressing renal disease 2.History of Type 1 diabetes mellitus 3.Patients with FPG =270mg/dl at screening to be excluded 4.Macroalbuminuria; defined as albumin-creatinine ratio of >500mg/g. 5.Estimated GFR 6.Current/chronic use of the following medication: thiazolidinedione (TZD), SU derivative, Glucagon like peptide 1 receptor agonist (GLP-1RA), (dipeptidyl peptidase 4 inhibitor) DPP-4I, SGLT-2 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs). Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study. 7.Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. 8.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e., sports injury, headache, or back ache). However, no such drugs can be taken within a timeframe of 2 weeks prior to renal testing 9.Current urinary tract infection and active nephritis 10.Recent ( 1 Acute coronary syndrome 2 Chronic heart failure (New York Heart Association grade II-IV) 3 Stroke or transient ischemic neurologic disorder 11.Complaints compatible with neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan) 12.Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN 13.(Unstable) thyroid disease; defined as free thyroxine (fT4) outside of laboratory reference values or change in treatment within 3 months prior to screening visit 14.History of or actual malignancy (except basal cell carcinoma) Active cancer personal history of cancer within 5 years. History of or actual severe mental disease (Have any other condition including drug or alcohol abuse or psychiatric disorder including dementia that precludes the participant from following and completing the protocol as per judgement of the investigator.) Substance abuse (alcohol: defined as >4 units/day) 15.Allergy to any of the agents used in the study 16.Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study. 17.Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. 18.History of diabetic ketoacidosis or hyperosmolar nonketotic coma. 19.Severe uncontrolled hypertension defined as SBP =150 mmHg and/or Diastolic Blood Pressure (DBP) =100 mmHg 20.Inability to understand the study proto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Adjusted Mean Change from Baseline in glycated Haemoglobin A1c (HbA1c) at Week 16.Timepoint: Baseline to Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adjusted Mean Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16. 2. Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (16 Weeks). 3. Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (16 Weeks). 4. Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c = 8% at the end of the study visit (16 Weeks). Safety Endpoints: 5. Hypoglycemic episodes during the study. 6. Changes in clinical laboratory parameters from baseline to end of the study visit (16 Weeks). 7. Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 16 Week of treatment period. Timepoint: Baseline to Week 16. | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed