Supporting Healthy Blood Sugar Levels and Metabolic Health in Individuals with Early Type 2 Diabetes and Metabolic Dysregulation.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: GlyFit: Each capsule of GlyFit contains approximately 700 mg, comprising approximately 650 mg of active ingredients and 50 70 mg of excipients. Metaberine (Berberine extract) 200 mg BCM‐95 Curcuminoids extract 200 mg Gymnema sylvestre extract 150 mg Alpha lipoic acid 100 mg Chromium picolinate 200 mcg Excipients q.s. (approximately 50 70 mg) Control Intervention1: Metformin: Stable prescribed dose of Metformin. CONDITION: Health Condition 1: E119‐ Type 2 diabetes mellitus without complications PRIMARY OUTCOME: Mean change in HbA1c from baseline to Day 180. ; Timepoint: Day 0 to Day 180 SECONDARY OUTCOME: Changes in metabolic health indicators. ; Assessment of overall clinical improvement in metabolic status. ; Proportion of subjects achieving 0.5 percentage reduction in HbA1c. ; Safety & tolerability, including monitoring of adverse events. ; Change in liver ultrasound findings.Timepoint: Day 0 to Day 180 INCLUSION CRITERIA: 1. Male or female subjects aged 18 to 65 years. 2. Subjects diagnosed with early Type 2 Diabetes Mellitus or Metabolic Dysregulation. 3. HbA1c between 6 to 8 at screening. 4. Evidence of metabolic dysregulation demonstrated by at least one of the following a. BMI 25 b. Waist circumference 90 cm men or 80 cm women c. Triglycerides 150 mg dL d. HDL 40 mg dL men or 50 mg dL women e. HOMA IR above laboratory upper limit of normal 5. Subjects who have been on a stable dose of oral antidiabetic medication for at least 3 months prior to screening applicable for subjects enrolled in Arm 2 and 3. 6. Newly diagnosed treatment naive subjects may be enrolled in Arm 1. 7. Subjects who are willing to comply with all study procedures and visits. 8. Subjects who are able to understand the study requirements and provide written informed consent.
Epistemonikos ID: 1f1aaa5facebc449707483bbd0b2703b8a59d98e
First added on: Oct 08, 2026