Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus

Inclusion criteria

• ✓. Participant is willing and able to sign a written ICF or e-ICF.
• ✓. Men or women ≥18 years of age at the time of signing ICF or e-ICF.
• ✓. Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
• ✓. Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
• ✓. Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening.
• ✓. Participant is able and willing to undergo fasting blood draw (i.e. at least 8 hours after last eating or drinking) as well as 7-point SMBG check for 3 consecutive days prior to designated scheduled visits by using a home glucometer that is provided by the study site.
• ✓. Participant on stable daily doses of metformin for at least 90 days prior to screening.
• ✓. Participant who are on metformin and not the following agents for at least 3 months prior to screening: DPP-4 inhibitors, alpha-glucosidase enzyme inhibitors, sulfonylureas, sodium-glucose transport 2 inhibitors, amylin analogues, thiazolidinediones, any insulin product, herbals, or ayurvedic agents. Participants are encouraged to follow the standard of care in their study regions, including appropriate diet and lifestyle modifications, rather than make abrupt change in the diabetic management prior to screening without consulting their physicians.