Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Arm 1: Dose Up-titration Period: Participants receive GL0034
starting at Dose Level 1 with titration up to Dose Level
2 for approximately 20 weeks
Maintenance Treatment Period: Once par
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to sign a written informed consent form (ICF) or electronic informed consent (e-ICF). 2.Men or women aged 18 years or older at the time of signing the consent. 3. Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening. 4. Participant has a HbA1c level of 7.0 10.5%, both inclusive, at the time of screening. 5. Participant has a stable BMI of 27 kg/m2 or higher for at least 90 days before screening. 6. 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. 7. Participant on stable daily doses of metformin for at least 90 days prior to screening. 8. 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. 9. If the participant is a woman of childbearing potential, she must agree to use a highly effective method of contraception during the study along with a barrier method, and continue the same method for at least one month after the last dose of the study drug. Highly effective methods include intrauterine device, injectable hormonal contraceptive, contraceptive patch or implant, partner s vasectomy, bilateral tubal occlusion, and sexual abstinence. Women of childbearing potential include those who are not surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (defined as 12 consecutive months of no menstruation without another medical cause). 10. Male participants with female partners of childbearing potential must use a barrier method of contraception (such as condom) if not surgically sterile (vasectomy) during the study. They must continue using the method for 30 days after the last dose and refrain from donating sperm during this period. If the female partner becomes pregnant during the study or within 30 days after the last dose, an informed consent form will be provided to monitor the female partner, pregnancy, and newborn. 11. If participant is a WOCP, she must have a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy at baseline, with results available before IP administration. 12. Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures. 13. Participant is willing and able to independently record the response on various scales and make entries using the e-Patient reported outcomes (ePRO) device.
Exclusion criteria
Exclusion criteria: 1. Participants who have a history of type 1 diabetes mellitus. 2. A self-reported change in more than 5 percent of body weight within 90 days before screening, irrespective of medical records. 3. History of pancreatitis (acute or chronic) or more than 3 hypoglycemic episodes (blood glucose level below 70 mg/dL or 3.9 mmol/L) within 90 days prior to screening. 4. Diagnosis of chronic kidney disease with estimated glomerular filtration rate below 60 5. Poorly controlled hypertension with systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg 6. Poorly controlled hypothyroidism defined as thyroid-stimulating hormone above 6 mIU/L or below 0.4 mIU/L 7. Diabetes mellitus and/or obesity that are induced by endocrine disorders (e.g. Cushing Syndrome) or medication use (e.g. corticosteroids) as judged by the Investigator. 8. Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed more than 1 year before screening is allowed). Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, previous interventions that, due to reversal or removal, does not have any influence on the participant s weight, in the opinion of the Investigator, are allowed. 9. History of major depressive disorder within 2 years before randomization. 10. History of other severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder). 11. Any lifetime history of a suicidal attempt. 12. Participants with any medical condition [i.e. gastroparesis, uncontrolled gastroesophageal reflux disease or diarrhea with or without a diagnosis of a diagnosis of irritable bowel syndrome] that, in the opinion of the Investigator, can confound study efficacy assessments or safety concerns. 13. Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to IP administration. 14. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2,sudden cardiac death, unexplained death, long QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member. 15. Surgery scheduled for the trial duration period, except for very minor surgical procedures in the opinion of the Investigator. 16. Participants with active malignancy. Note: participants with past history of malignancy may be included if: - Participant has history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator s judgement. - Participant has history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator s judgement. 17. Presence of diabetic retinopathy [both nonproliferative diabetic retinopathy and proliferative diabetic retinopathy] or maculopathy in either eye that was verified by a fundoscopic examination within 90 days prior to screening or during the study. 18. Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study. 19. Participants with any other condition, which in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants Timepoint: Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of participants with an HbA1c of less than 7.0%, less than 6.5%, or less than 5.7%Timepoint: Week 36 or Week 48;Change in HbA1c levels from baseline (Week 0) to Week 48Timepoint: Week 48;Change in HbA1c levels over time from baseline (Week 0) to Week 48 following treatments in all participantsTimepoint: Week 48;Percent change (%) in body weight and BMI from baseline (Week 0) to Week 36, Week 48, and over time from baseline to Week 48 following treatments in all participants.Timepoint: Week 36 and week 48;Percent of participants who achieved at least 5%, at least 10%, at least 15%, more than 20%, and more than 25% from baseline to Week 36 or Week 48 of treatments in all participantsTimepoint: Week 36 or Week 48 | — |
Countries
India, United States of America
Contacts
Public ContactShruti Pal
Sun Pharmaceutical Industries Ltd
Outcome results
None listed