Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Torrent Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female T2DM patients 18 to 75 years. 2. T2DM cases with uncontrolled Hyperglycemia either with mono or dual or triple (as per discretion of physician) OADs or insulin and having HbA1c 7-10 percent
Exclusion criteria
Exclusion criteria: 1. HbA1c greater than 10 percent 2. T1DM 3. Clinical history of hypersensitivity or DKA 4. Clinical history of Active or uncontrolled ASCVD or Heart failure or Retinopathy or Neuropathy 5. Clinical history of CKD (eGFR less than 45 ml per min per m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change from baseline in HbA1c 2. Mean change in FPG, 2-hr PPBG Timepoint: 1. at week 12 2. from baseline at week 4 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c assessment for cases with Young Onset Diabetes (Age 18 to 40y)Timepoint: at week 12;Change from baseline in HbA1c assessment for Overall and CV risk cases (with QRISK-3 score greater than 10 percent involving multiple risk factors, LVD, Stage 3a CKD, Age greater than or equal to 40y, Personal or Family History of ASCVD)Timepoint: at week 12;Changes in dose of baseline sulfonyl urea/insulinTimepoint: at 4 and 12 weeks;Mean change from baseline in HbA1c in patients with DPP4i/Met, SGLT2i/Met, SU/Met and/or insulin and/or GLP1aTimepoint: at week 12;Safety of Imeglimin SRTimepoint: at week 4 and week 12;Treatment responders with target HbA1c achievement of less than 7 percent in Overall, CV risk and YoD casesTimepoint: at week 12 | — |
Countries
India
Contacts
Public ContactDr Lokesh RV
Bharti Hospital
Outcome results
None listed