Health Condition 1: - Health Condition 2: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
Intervention1: Gliclazide EXTENDED RELEASE 60mg (DIAMICRON�® XR 60): Gliclazide EXTENDED RELEASE 60mg (DIAMICRON�® XR 60), orally, once daily at breakfast time. The doses will be titrated every
Sponsors
DrVMohan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult Patients aged 7-30 (ends inclusive) of either gender diagnosed who are diagnosed with MODY 1, MODY 3 or MODY 12 2. Body Mass Index ( 3. Family history of diabetes in one or both of the parents 4. Duration of diabetes less than 2 years 5. Patients who understands the nature of study and willing to provide a written informed consent
Exclusion criteria
Exclusion criteria: Patient will excluded if they have any of the following: 1. Type 1 diabetes 2. Type 2 diabetes 3. Gestational diabetes 4. Fibrocalculous pancreatic diabetes 5. Presence of acanthosis nigricans or severe obesity 6. History of serious infection / surgical procedure / Severe trauma in past 4 weeks or planned surgery during the study period of 12 weeks 7. History or evidence of significant cardiovascular disorder including but not limited to, heart failure, myocardial infarction or any conduction abnormality on ECG viz QT prolongation, Arrhythmias 8. History or risk of Acute Pancreatitis 9. History of Chronic Alcoholism or drug abuse 10. Pregnant or breast-feeding women 11. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c level from baseline to end of 52 weeksTimepoint: 1. Change in HbA1c level from baseline to end of 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Change in fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) level from baseline to end of 52 weeks.Timepoint: 1. Incidence of adverse events and serious adverse events 2. hypoglycemia events 3. vital signs (weight, BMI) and Laboratory values | — |
Countries
India
Contacts
Public ContactDrVMohan
Madras Diabetes Research Foundation
Outcome results
None listed