A study to test the benefits and safety of GL0034 in people with type 2 diabetes who are overweight or obese and have health problems related to their weight
Scientific Title of Study
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Tolerability of GL0034 Among Type II Diabetes Mellitus Subjects Who Are Obese or Overweight With Weight-related Comorbidities
Dept of Endocrinology and Metabolism, Biotechnology Block, 3rd Floor, Room no. 313, AIIMS, New Delhi, near Gate no. 02,
All India Institute of
Medical Sciences,
Ansari Nagar, New
Delhi - 110029
South DELHI
CARE CHL Hospitals, Unit of Convenient Hospitals Ltd
Clinical Research Dept.,3rd Floor, Behind IT Dept,CARE CHL Hospitals, Near L. I. G. Square, A. B. Road, Indore - 452008,Madhya Pradesh, India Indore MADHYA PRADESH
9977999687
sandeep_julka@yahoo.com
Dr Neeta R Deshpande
Centracare Super Speciality Hospital Unit Of NDG Sevasadan Super Speciality
810, Dept.
Endocrinology,
Diabetes and
Metabolism, Christian
Medical College,
Vellore, Tamil Nadu,
India, 632004
Vellore TAMIL NADU
9500249665
nitin.endocrine@gmail.com
Dr Vaishali Chetan Deshmukh
Deenanath Mangeshkar Hospital & Research Centre
Department of
Endocrinology,
Superspeciality
building Ground Floor,
Erandawane, Pune
411004, Maharashtra. Pune MAHARASHTRA
9850811450
drvaishaliresearch@gmail.com
Dr Surendra Kumar Sharma
Diabetes Thyroid & Endocrine Centre
A-1, Madrampura, Near 4 no. ESI Hospital, Ajmer Road, Sodala, Jaipur-302006, India
Jaipur RAJASTHAN
9829010233
sksharmacr@gmail.com
Dr Kongara Srikanth
Endolife Specialty Hospitals Pvt. Ltd.
D No. 12-12-94, Old Club
Road, 1st Floor,
Kothapet, Guntur,
Andhra Pradesh,
India,522001 Guntur ANDHRA PRADESH
9849945577
srikanthendo@gmail.com
Dr Sharvil Gadve
Excel Endocrine Centre
CTS 1556, Plot no 52, Sharanya Towers, 2nd Lane Rajarampuri, Opposite Hotel Castle Kolhapur-416008 Kolhapur MAHARASHTRA
9552365977
sharvilgadve@gmail.com
Dr Aquil Kalanad
Government Medical College
Government Medical
College, Kozhikode,
Mavoor road, Medical
College Junction 17,
Kozhikode, 673008,
Kerala, India Kozhikode KERALA
98956 71695
aquilkalanad@gmail.com
Dr Jothydev Kesavadev
Jothydevs Diabetes Research Centre
Department of Clinical Research, Research unit, Room No: 25, JDC Junction,
Konkalam Road,
Mudavanmugal,
Poojappura,
Trivandrum, India,
695032 Thiruvananthapuram KERALA
9895040055
jothydev@gmail.com
Dr Anupam Prakash
Lady Hardinge Medical College and S.S.K. Hospital
Room No. 1014, Dept.
of Medicine, Lady
Hardinge Medical
College and S.S.K.
Hospital, Shaheed
Bhagat Singh Marg,
New Delhi- 110001 New Delhi DELHI
8588885305
prakashanupam@hotmail.com
Dr L Sreenivasa Murthy
Life Care Hospital and Research Centre
Life Care Hospital and Research Centre, 1st floor, Research wing
2748/2152 M.L.N
Enclave, 16th East
Cross Road, 8th Main,
D block, Next to Union
Bank of India,
Sahakarnagara,
Bangalore, Karnataka,
India, 560092 Bangalore KARNATAKA
9448051046
drlsm@lcrc.in
Dr Viswanathan Mohan
Madras Diabetes Research Foundation
No:04 Conran Smith
Road, Gopalapuram,
Chennai - 600086
Chennai TAMIL NADU
044-43968888
drmohans@diabetes.ind.in
Dr Desai Piyush Harshadrai
Nirmal Hospital Private Limited
Nirmal Hospital Private Limited, Ring Road, Sagrampura, Surat, 395002, Gujarat Surat GUJARAT
9825144453
drpiyushdesai@gmail.com
Dr Bandgar Tushar Ramkrishna
Seth G. S. medical college and KEM hospital
Department of
Endocrinology and
Metabolism, Seth G S
Medical College and
KEM Hospital, Parel,
Mumbai 400012,
Maharashtra, India Mumbai MAHARASHTRA
9820025037
drtusharb@gmail.com
Dr Nikhil Madhusudan Bhagwat
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Department of Endocrinology, 4th
Floor, Room No. 419, College Building, Dr.
A.L. Nair Road, Mumbai central,
Mumbai, Maharashtra, India, 400008
Mumbai MAHARASHTRA
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.
ExclusionCriteria
Details
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 interferes with assessment/interpretation of study outcomes).
20. Known hypersensitivity to the study IP or its excipients.
21.History of alcohol or drug abuse in the previous two years. Alcohol abuse in this study is defined as more than 14 standard drinks per week in men or more than 7 standard drinks per week in women, with or without a history of alcohol withdrawal symptoms, institutionalization or hospitalization due to alcohol use, or binge drinking with more than 5 standard drinks on a single occasion in men or more than 4 standard drinks on a single occasion in women.
22. Participants are taking, or will start medications with narrow therapeutic index such as digoxin, warfarin, etc.., or those that will prolong QTc interval.
23. Participants received any medications for the treatment of type II diabetes mellitus other than those stated in the inclusion criteria within 90 days before screening. Short term insulin treatment for a maximum of 7 days prior to screening is allowed. Prior insulin treatment for gestational diabetes is also allowed.
24. Participants who have used medications in the family of GLP-1 agonists in the past.
25. Treatment with any herbal diet supplements, over-the-counter diet medications as an attempt to lose weight within 90 days before screening.
26. Treatment with orlistat, lorcaserin, zonisamide, topiramate, phentermine, buproprion, or naltrexone that could promote weight loss within 90 days before screening.
27. Participation in any organized or online weight-reduction program (i.e. WeightWatchers) within 90 days before screening.
28.Screening calcitonin level equal to or greater than 50 ng/L (pg/mL).
29. Participants having clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, renal, hepatic, neurological, endocrine, gastrointestinal, psychiatric etc.) that, in the opinion of the Investigator, would put the participant at risk by participating in the study.
30. Participants with positive urine drug screen [amphetamine, barbiturate, benzodiazepine, cocaine, opiates] with substances that are not part of participant’s routine medical care. Tetrahydrocannabinols is acceptable for as long as its use is legally allowed by participant’s home state or country.
31. Participants have clinically significant ECG abnormality , including QTcF >450 msec for males and >470 msec for females, or at high risk for arrhythmia such conditions listed in Criteria #13 above, brady-arrhythmias, tachy-arrhythmias, ventricular arrhythmias, torsade de pointes, high-degree atrioventricular block, or New York Heart Association Class III and IV congestive heart failure.
32. Pregnant or lactating females.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1.Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants
Week 36
Secondary Outcome
Outcome
TimePoints
The number of participants with an HbA1c of less than 7.0%, less than 6.5%, or less than 5.7%
Week 36 or Week 48
Change in HbA1c levels from baseline (Week 0) to Week 48
Week 48
Change in HbA1c levels over time from baseline (Week 0) to Week 48 following treatments in all participants
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.
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 participants
Week 36 or Week 48
Target Sample Size
Total Sample Size="285" Sample Size from India="120" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This Phase II clinical trial evaluates the safety and effectiveness of GL0034, a weekly injectable drug, in adults with type II diabetes who are overweight or obese. The study compares different doses of GL0034 with placebo over 48 weeks. Key outcomes include changes in blood sugar (HbA1c), body weight, and related health markers. The trial also monitors side effects, quality of life, and other health indicators through lab tests, imaging, and questionnaires.