Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to provide informed consent 2. Female or male patients aged 18 years or above 3. Adult patient with inadequately controlled T2DM with a HbA1C between 7.0% and 10.0% despite using diet plus exercise and/or antidiabetic agents 4. Requirement for Voglibose as monotherapy or add-on therapy 5. Patients must provide written consent to use personal and/or health data prior to the entry into the study
Exclusion criteria
Exclusion criteria: 1. Patients with Type 1 diabetes mellitus 2. Any medical condition of the patient which in opinion of investigator would interfere with safe completion of the study 3. History of frequent attack of hypoglycemia or loss of consciousness due to hypoglycemia 4. Has history of ketoacidosis or hyperosmotic status/coma 5. Pregnancy or lactation 6. Women of child bearing potential not ready to use an effective contraceptive method during the study 7. Patients participating in any other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c levels at week 12Timepoint: Visit 1 at Baseline Visit 2 at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in FBG and PPBG levels at week 12 2. Usage pattern of voglibose as monotherapy or add-on with other OADs 3. Change from Baseline in body weight at week 12 4. Adverse events associated with voglibose useTimepoint: Visit 1 at Baseline Visit 2 at week 12 | — |
Countries
India
Contacts
Public ContactDr Rahul Mandlik
Torrent Pharmaceuticals Ltd
Outcome results
None listed