| CTRI Number |
CTRI/2019/09/021342 [Registered on: 19/09/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease |
|
Scientific Title of Study
|
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT03819153 |
ClinicalTrials.gov |
| NN9535-4321, Version 4.0, Dated 11 November 2020 |
Protocol Number |
| U1111-1217-6259 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sreenivasa Murthy |
| Designation |
Principal Investigator |
| Affiliation |
LIFECARE HOSPITAL AND RESEARCH CENTRE |
| Address |
First Floor, LIFECARE HOSPITAL AND RESEARCH CENTRE, #2748/2152, M L N ENCLAVE, 16th E Cross, 8th Main, D Block, Next to Corporation Bank, SAHAKARNAGAR
Bangalore
KARNATAKA
560092
India |
| Phone |
|
| Fax |
|
| Email |
drlsm@lcrc.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Maya Sharma |
| Designation |
Vice President - Clinical, Medical, Regulatory & Pharmacovigilance |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
080-41123517 |
| Email |
yrms@novonordisk.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Maya Sharma |
| Designation |
Vice President - Clinical, Medical, Regulatory & Pharmacovigilance |
| Affiliation |
Novo Nordisk India Private Ltd. |
| Address |
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,
Bangalore - 560045. India
Bangalore
KARNATAKA
560045
India |
| Phone |
9911497869 |
| Fax |
080-41123517 |
| Email |
yrms@novonordisk.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novo Nordisk India Private Limited,
Nxt Tower - 2, Floor 1 & 2
Embassy Manyata Business Park,
Nagavara Village, Kasaba Hobli,Bangalore - 560045. India
Tel No.:080-40303200
India |
|
|
Primary Sponsor
|
| Name |
Novo Nordisk AS |
| Address |
Novo Allé, 2880 Bagsvaerd Denmark |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
Poland
Russian Federation
Slovakia
South Africa
Spain
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Deewan |
Ajanta Research Centre |
Department of Nephrology, #765, ABC Complex,Kanpur Road,Alambagh,Lucknow-226005
Lucknow
UTTAR PRADESH |
9936507362
drdeepakdewan@rediffmail.com |
| Dr Harish Kumar |
Amrita Institute of medical Sciences & Research Centre |
Department of Endocrinology & Daibetes
AIMS
Ponnekara. P.O., Kochi-682041, Kerala
Ernakulam
KERALA |
9895545190
harishkumar@aims.amrita.edu |
| Dr Manish Kumar Jain |
Apollo Gleneagles Hospital |
Department of Nephrology, 58, Canal Circular Road, Kolkata - 700 054, West Bengal
Kolkata
WEST BENGAL |
9831037493
manish_dr_jain@yahoo.in |
| Dr Anil Kumar B T |
BGS Global Hospitals |
Department of Nephrology, Room No: 134, BGS Health & Educational City Uttarahalli Road, Kengeri, Bengaluru - 560060
Bangalore
KARNATAKA |
9916950554
anilbuskal@yahoo.co.in |
| Dr Kongara Srikanth |
Endolife Speciality Hospital Pvt Ltd |
D-NO:12-12-94, Old Club Road
Kothapet, Guntur-522001
Andhra Pradesh
Guntur
ANDHRA PRADESH |
9849945577
srikanthendo@gmail.com |
| Dr Jayakumar E K |
Government Medical College |
Department of Nephrology, Super Speciality building , Kozhikode-673008, Kerala
Kozhikode
KERALA |
9447232900
jayakumarek@gmail.com |
| Dr Tukaram Jamale |
KEM Hospital |
Department of Nephrology, Ward No. 34A, old hospital building, 3rd floor, KEM Hospital, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA |
9167460362
tukaramjamale@yahoo.co.in |
| Dr Sreenivasa Murthy L |
LIFECARE hospital and research centre |
#2748/2152, M L N Enclave , 16th E cross
8th main, D Block, Next to corporation bank
Sahakar Nagar, Bengaluru 560092
Bangalore
KARNATAKA |
9448051046
drlsm@lcrc.in |
| Dr Gireesh M S |
M S Ramaiah Medical College and Hospital |
Department of Nephrology, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054.
Bangalore
KARNATAKA |
9916488899
neph.gireesh@msrmh.com |
| Dr Sandeep Kumar Gupta |
M.V Hospital and Research Centre |
314/30, Mirza Mandi, Chowk,Lucknow-226003, UP,
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Georgi Abraham |
Madras Medical Mission |
Department of Nephrology, The Madras Medical Mission, Room no T-316, 4-A, Dr J Jayalalitha Nagar, Mogappair,Tamil Nadu.
Chennai
TAMIL NADU |
4426565961
abraham_georgi@yahoo.com |
| Dr Dinesh Khullar |
Max Healthcare Super Speciality Hospital |
1, Press Enclave Road, Saket, New Delhi - 110 017
New Delhi
DELHI |
9810124066
drdineshkhullar@gmail.com |
| Dr Manisha Sahay |
Osmania Medical College and Osmania General Hospital |
QQDC Building,Department of Nephrology, Room # 444, 3rd floor,afzalgunj, Hyderabad-500012
Hyderabad
TELANGANA |
9849097507
drmanishasahay@gmail.com |
| Dr Mohan Magdum |
Poona Hospital and Research Centre |
Department of endocrinology, Near Psychiatric OPD, L.B. Shastri Road, 27, Sadashiv Peth, Pune- 411030, Maharashtra 411030
Pune
MAHARASHTRA |
9822217243
mohanmagdum@gmail.com |
| Dr Anil Kumar Bhalla |
Sir Gangaram Hospital |
Department of Nephrology, Room No. 1298, Old Rajendra Nagar,New Delhi 110060
New Delhi
DELHI |
9811047377
bhallaak@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethics Committee, M.S. Ramaiah Medical College and Hospitals, Bangalore |
Approved |
| Institutional Ethic Committee, Ajanta Hospital and IVF Centre, Lucknow |
Approved |
| Institutional Ethics Committee Amrita Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Endolife Speciality Hospitals |
Approved |
| Institutional Ethics Committee Osmania Medical College |
Approved |
| Institutional Ethics Committee, Apollo Gleneagles Hospital, Kolkata |
Approved |
| Institutional Ethics Committee, BGS Global Hospitals, Bangalore |
Approved |
| Institutional Ethics Committee, Government Medical College, Kozhikode |
Approved |
| Institutional Ethics Committee, M V Hospital and Research centre |
Approved |
| Institutional Ethics Committee, Poona Hospital and Research Centre, Pune |
Approved |
| Institutional Ethics Committee, The Madras Medical Mission, Chennai |
Approved |
| KEM Hospital Research Centre Ethics Committee, Mumbai |
Approved |
| Life Care Hospital Institutional Review Board |
Approved |
| Max Health care Ethics committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (semaglutide) |
Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study. |
| Intervention |
Semaglutide |
Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with type 2 diabetes mellitus
2. HbA1c less than or equal to 10 percent (less than or equal to 86 mmol per mol)
3. Renal impairment defined either by:
a. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL per min per 1.73 meter square (CKD-EPI) and UACR greater than 300 and less than 5000 mg per g or
b. serum creatinine-based eGFR greater than or equal to 25 and less than 50mL per min per 1.73 meter square (CKD-EPI) and UACR greater than 100 and less than 5000 mg per g
4. Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system blocking agent including an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening. |
|
| ExclusionCriteria |
| Details |
Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Planned coronary, carotid or peripheral artery revascularisation
Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease |
Week 0 to month 61 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope) |
Week 0 to month 61 |
| Time to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death |
Week 0 to month 61 |
| Time to occurrence of all-cause death |
Week 0 to month 61 |
| Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint |
Week 0 to month 61 |
| Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation |
Week 0 to month 61 |
| Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope) |
Week 12 to month 61 |
| Change in eGFR (CKD-EPI) |
Week 0, Week 12 |
| Change in eGFR (cystatin C CKD-EPI) |
Week 0, Year 3 |
| Relative change in urinary albumin-to-creatinine ratio (UACR) |
Week 0, Year 3 |
| Change in body weight |
Week 0, Year 3 |
| Change in glycosylated haemoglobin (HbA1c) |
Week 0, Year 3 |
| Change in systolic blood pressure |
Week 0, Year 3 |
| Change in diastolic blood pressure |
Week 0, Year 3 |
| Number of severe hypoglycaemic episodes |
0 to month 61 |
|
|
Target Sample Size
|
Total Sample Size="3016"
Sample Size from India="205"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
17/06/2019 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="11"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo (’dummy medicine’). This is known as participants’ study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer. |