Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Sponsors
Mr Ghanshyam Goti
Eligibility
Inclusion criteria
Inclusion criteria: Patients between 18-60 (both inclusive) age, both sex. Patients receiving Oral Hypoglycemic Agents and/or insulin as on-going treatment for diabetes Haemoglobin A1C (HbA1c) >6.5% and Subjects having a body mass index (BMI) of 20 to 35 kg/m2. Fasting Plasma Glucose (FPG) >120 mg/dL and < 450 mg/dL (both inclusive)
Exclusion criteria
Exclusion criteria: •Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. •Women who are pregnant or lactating • Smokers/Alcoholics and/or drug abusers •Patients with evidence of malignancy •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.) •Involvement in any other study requiring drug therapy •Renal dysfunction as evidenced by raised serum creatinine from renal function test •Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) •Unwillingness to undergo therapy •Known hypersensitivity to any of the ingredients of study tablets •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change from Baseline in Fasting Plasma Glucose (FPG). To assess change from Baseline in 2 Hr. Post Meal Glucose (PMG) to 60 days. To evaluate change from Baseline in Haemoglobin A1c (HbA1c) To assess change from Baseline in Fasting Insulin (FI) To assess change from Baseline in 2 hr. Post Meal Insulin (PMI). Timepoint: Baseline and end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in dose of OHAs To evaluate changes of [HOMA]-b, insulin resistance (IR) by HOMA-IR To evaluate C-Peptide level Evaluation of Urine sugar Subjective assessment of the clinical symptoms To evaluate tolerability and safety To assess change from Baseline in lipid profile to 60 days. Assessment of vitals during the study period Global assessment for overall improvement by the subject and investigator Quality of Life Instrument for Indian Diabetes Patients Timepoint: Baseline and 60 days | — |
Countries
India
Contacts
Public ContactDr Shridhar Pandya
Gplife Healthcare Pvt Ltd
Outcome results
None listed