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CTRI Number  CTRI/2023/04/051344 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of weekly basal insulin compared with daily insulin glargine in adult participants with type 2 diabetes 
Scientific Title of Study   A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults with Type 2 Diabetes on Multiple Daily Injections 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
I8H-MC-BDCV protocol amendment (a) dated 10 May 2022  Protocol Number 
NCT05462756  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Arora 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Arora 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India


HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  arora_rohit@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Associate Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd 
Address  Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Germany
India
Italy
Mexico
Spain
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Chawla  BSES MG Hospital  Clinical Research Office, 7th Floor, Inside waiting room, SV Road, Opp. Railway Station, Andheri West, Mumbai, Maharashtra, 400058
Mumbai
MAHARASHTRA 		 9820002333

drmanojchawla@yahoo.com 
Dr Sreenivasa Murthy  Life Care Hospital and Research Centre  #2748/2152, M L N Enclave, 16th E Cross, 8th Main, D Block, Sahakaranagara, Next to Corporation Bank, Bangalore, Karnataka, India, 560092
Bangalore
KARNATAKA 		 9448051046

drlsm@lcrc.in 
Dr Viswanathan Mohan  Madras Diabetes Research Foundation  Department of Clinical Trials, No.4, Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu, India, 600086
Chennai
TAMIL NADU 		 9840134505

drmohans@diabetes.ind.in 
Dr Kudugunti Neelavani  Osmania General Hospital  Department of Endocrinology, Room No 306, 2nd Floor, Golden Jubilee Block, Afzalgunj, Hyderabad, Telangana, India, 500012
Hyderabad
TELANGANA 		 919848131182

neelaveni1@yahoo.co.in 
Dr Rama Walia  Postgraduate Institute of Medical Education & Research  Department of Endocrinology, Sector 12, Block B, 3rd Floor, Room no.3029, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9872997438

ramawalia@rediffmail.com 
Dr Jugal Gada  Topiwala National Medical College & B.Y.L. Nair Charitable Hospital  Department of Endocrinology, 4th Floor, Room no.419, College Building, T.N. Medical College and B.Y.L Nair Ch. Hospital, Mumbai Central, Maharashtra, 400008, India.
Mumbai
MAHARASHTRA 		 9819893087

jugal.gada@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
BSES MGH Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee of Madras Diabetes Research Foundation  Approved 
Institutional Ethics Committee, Osmania Medical College  Approved 
Lifecare Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Insulin Glargine  Once-daily subcutaneous injection. The dose is individualized by study doctor. The study will last about 34 weeks. 
Comparator Agent  Insulin lispro  Subcutaneous injection with meals. The dose is individualized by study doctor. The study will last about 34 weeks. 
Intervention  LY3209590  Once-weekly subcutaneous injection. The dose is individualized by study doctor. The study will last about 34 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
2. Are receiving ≥10 units of total basal insulin per day at screening.
3. Are receiving ≤2 units/kilogram/day of total daily insulin at screening
4. Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
5. Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
-once daily U-100 or U-200 insulin degludec
-once daily U-100 or U-300 insulin glargine
-once or twice daily U-100 insulin detemir or
-once or twice daily human insulin Neutral Protamine Hagedorn
6. Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur prior to the evening meal.
-Insulin lispro-aabc
-Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)
-Insulin aspart (U-100)
-Insulin glulisine (U-100), or
-Regular insulin (U-100)
7. Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
-dipeptidyl peptidase IV inhibitors
-sodium-glucose co-transporter-2 inhibitors
-biguanides (for example, metformin), or
-glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
-Have a body mass index ≤45 kilogram/square meter (kg/m²) 
 
ExclusionCriteria 
Details  1. Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
2. Are currently receiving any of the following insulin therapies anytime in the past 90 days:
-insulin mixtures
-insulin human, inhalation powder, or
-continuous subcutaneous insulin infusion therapy, or
-regular insulin U-500
3. Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
4. Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
5. Have hypoglycemia unawareness in the opinion of the investigator
6. Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
7. Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
8. Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from Baseline in HbA1c  Baseline, Week 26 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage of Participants Achieving HbA1c less than 7% without Nocturnal Hypoglycemia
2. Basal Insulin Dose
3. Bolus Insulin Dose
4. Total Insulin Dose
5. Basal Insulin Dose to Total Insulin Dose Ratio 		 Week 26 
1. Nocturnal Hypoglycemia Event Rate
2. Hypoglycemia Event Rate 		 Baseline to Week 26 
1. Change from Baseline in Fasting Glucose
2. Change from Baseline in Body Weight 		 Baseline, Week 26 
1. Time in Glucose Range
2. Time in Hypoglycemia Range
3. Time in Hyperglycemia Range
4. Glucose Variability 		 Week 22 to Week 26 
 
Target Sample Size   Total Sample Size="670"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "730"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2023 
Date of Study Completion (India) 27/02/2024 
Date of First Enrollment (Global)  11/08/2022 
Date of Study Completion (Global) 27/02/2024 
Estimated Duration of Trial   Years="0"
Months="5"
Days="16" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org

  6. For how long will this data be available start date provided 01-05-2023 and end date provided 31-10-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The reason for this study is to evaluate if the once-weekly study drug LY3209590 is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks. 
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