A study to investigate the blood sugar lowering effect of EN-DM-02, EN-DM-04 and EN-DM-05 in comparison with placebo in drug naïve/medication free patients with Type II Diabetes Mellitus under Protocol ID: VL/090707/EN/DM/EN-DM-05

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: Intervention1: EN‐DM‐04: 1 Tablet twice daily for 12 weeks Intervention2: EN‐DM‐05: 1 Tablet twice daily for 12 weeks Intervention3: EN‐DM‐02: 1 Tablet twice daily for 12 weeks Control Intervention1: Placebo: 1 Tablet once daily from Day 1 to Day 28. 1 Tablet twice daily from Day 28 to Day 112 CONDITION: Drug naïve/medication free patients with Type II Diabetes Mellitus PRIMARY OUTCOME: To determine if any or all of the Investigational Products (IPs) ? EN‐DM‐04, EN‐DM‐02 and EN‐DM‐05 are significantly better than placebo in reducing fasting blood sugar levels (FBS) as compared to Day 25 in patients with Type II Diabetes mellitus‐‐‐‐‐‐Timepoint: Fasting Blood Sugar SECONDARY OUTCOME: To determine if any or all of the Investigational Products (IPs) ? EN‐DM‐04, EN‐DM‐02 and EN‐DM‐05 are significantly better than placebo in reducing HbA1c and FBS as compared to the baseline in patients with Type II Diabetes mellitus; To determine if the combination product EN‐DM‐05 is more efficacious in lowering HbA1c and /or FBS as compared to EN‐DM‐02 and EN‐DM‐04; ‐‐‐‐‐‐Timepoint: Fasting Blood Sugar (FBS); Glycosylated haemoglobin (HbA1c) INCLUSION CRITERIA: 1) Patients with Type 2 diabetes mellitus, with FBS 150‐180 mg/dl and HbA1c of 7% to 8.5 % who are either drug ?naïve or have been medication free for at least 3 months 2) Body Mass Index between 18.5 and 30 kg/m2 Patients willing and able to follow diet and exercise regime for the study duration
Epistemonikos ID: e8da6aab2cf3c35403407f21ba3bbf538ad07c96
First added on: Aug 22, 2024