Chellaram Diabetes Institute, OPD No.55, 1 floor, Lalani Quantum, Bavdhan (Budruk), Pune-Bangalore bypass Highway, NH-4. Pune-411021, Maharashtra, India Pune MAHARASHTRA
020-66839777
uagcdi@cdi.org.in
Dr Hemant Gupta
Grant Govt. Medical College & Sir J. J. Group of Hospitals
OPD 20, Department of Medicine, OPD building, Grant Government Medical College and Sir J J Group of Hospitals, Byculla, Mumbai – 400008, Maharashtra, India Mumbai MAHARASHTRA
9820095763
drhemantgupta@hotmail.com
Dr Bongi Vivekanand
King George HospitalÂ
Department of Endocrinology, Super Specialty block 3rd floor, King George Hospital, Andhra Medical College, Maharanipeta, Visakhapatnam – 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9440514756
drvivek78@gmail.com
Dr R Balamurugan
Kovai Diabetes Speciality Centre and Hospital
Kovai Diabetes Speciality Centre & Hospital, #15, Vivekananda Road, Ram Nagar, Coimbatore-641009, Tamilnadu, India Coimbatore TAMIL NADU
9842244881
rbmkdsc@gmail.com
Dr Vijay Viswanathan
M.V. Hospital for Diabetes
MV Hospital for Diabetes Pvt Ltd, #4, West Madha Church Street, Royapuram, Chennai – 600013, Tamilnadu, India
Chennai TAMIL NADU
9840055535
drvijay@mvdiabetes.com
Dr Animesh Maiti
Medical College and Hospital
Department of Endocrinology, 88, College Street, College Square Kolkata, 700073 (India) Kolkata WEST BENGAL
9433936076
animeshmaiti73@gmail.com
Dr Rakesh Sahay
Osmania General Hospital
Room no:306 Department of Endocrinology, 2nd floor, OP Building, Osmania General Hospital, Osmania Medical College, A fzalgunj, Hyderabad, Telangana, India-500012 Hyderabad TELANGANA
9849597507
sahayrk@gmail.com
Dr Sudhir Bhandari
Rajasthan University of Health Sciences
Rajasthan University of Health Sciences Hospital, Sector 11, Kumbha Marg , Pratap Nagar, Jaipur – 302033, Rajasthan, India Jaipur RAJASTHAN
9829078844
Drs_bhandari@yahoo.com
Dr Bal Kishan Gupta
S. P. Medical College & A G Hospitals
Medical OPD, Room No. 16, S. P. Medical College and AG Hospitals, Bikaner – 334003, Rajasthan, India Bikaner RAJASTHAN
9829176143
bkgbkn@rediffmail.com
Dr Uday Phadke
Sahyadri Super Speciality Hospital
Sahyadri Super Speciality Hospital, 30 C, Erandwane, Karve Road, Pune – 411004, Maharashtra, India Pune MAHARASHTRA
2067213000
uday@drudayphadke.com
Dr Sanjeev R Phatak
Vijayratna Diabetes Diagnosis and Treatment Center
Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Near Parimal Underbridge and Suvidha Shopping Centre, Paldi, Ahmedabad – 380007, Gujarat, India Ahmadabad GUJARAT
Ethics Committee, Prof. M. Vishwanathan Diabetes Research Centre
Submittted/Under Review
Ethics Committee, S.P. Medical College
Submittted/Under Review
Institutional Ethics Committee For Human Research, Medical College Kolkata
Submittted/Under Review
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital
Approved
Institutional Ethics Committee, GGMC, Mumbai
Submittted/Under Review
Institutional Ethics Committee, King George Hospital, Andhra Medical College
Approved
Institutional Ethics Committee, Osmania Medical College
Approved
Pranav Diabetes Center Ethics Committee
Submittted/Under Review
RUHS-CMS Institutional Ethics Committee
Submittted/Under Review
Sahyadri Hospitals Pvt Ltd Ethics Committee
Approved
Thakershy Charitable Trust Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Lyumjev
Multiple daily subcutaneous injection prior to each meal. Each injection will contain 100 U/mL of Lyumjev in 3 mL cartridge. The treatment duration will last up to 26 weeks.
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Subjects diagnosed (clinically) with T2DM for ≥1 year prior to screening.
2. Treated for ≥90 days prior to screening with MDI therapy
a. On basal insulin (insulin glargine 100 U/mL [Basaglar or Lantus] or insulin glargine 300 U/mL, insulin detemir, insulin degludec U-100, or NPH insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro 100 U/mL or 200 U/mL, insulin aspart, insulin glulisine, regular insulin, Fiasp® fast-acting insulin aspart), OR
b. premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily except for IDegAsp injected once daily
3. May have been treated with up to 3 OAMs including metformin, sodium-glucose cotransporter (SGLT)-2 inhibitor, dipeptidyl peptidase (DPP)-4 inhibitor, sulfonylurea, meglitinide, or alpha glucosidase inhibitor in accordance with local regulations. The dose of all OAMs must have been stable for ≥90 days prior to screening
4. Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening
5. Body mass index ≤45.0 kg/m2
ExclusionCriteria
Details
1. Having any other condition (including known drug or alcohol abuse, psychiatric disorder including eating disorder) that precludes the subject from following and completing the protocol
2. Have been diagnosed, at any time, with T1DM or latent autoimmune diabetes in adults
3. Have hypoglycemia unawareness as judged by the investigator
4. Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening
5. Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening
6. Have a known diagnosis of secondary diabetes (for example, diabetes caused by hemochromatosis, acromegaly, chronic pancreatitis, or pancreatectomy)
7. Excessive insulin resistance defined as having received a total daily dose of insulin >2.0 U/kg at the time of screening
8. Have a history of or are being evaluated for bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve
9. Have cardiovascular disease, within the past 6 months prior to screening, defined as stroke, decompensated heart failure (New York Heart Association Class III or IV), myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft
10. Renal:
a. History of renal transplantation
b. Currently receiving renal dialysis
c. Serum creatinine >2.0 mg/dL (177 μmol/L) at screening
11. Hepatic: Have obvious clinical signs or symptoms of liver disease (for example, acute or chronic hepatitis or cirrhosis), or elevated liver enzyme measurements as indicated below at screening:
a. Total bilirubin level (TBL) ≥2X the upper limit of normal (ULN [with the exception of Gilbert’s disease]) as defined by the central laboratory, or
b. Alanine aminotransferase (ALT) ≥3X ULN as defined by the central laboratory, or
c. Aspartate aminotransferase (AST) ≥3X ULN as defined by the central laboratory.
12. Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
13. Having any hypersensitivity or allergy to any of the insulins or excipients used in this trial
14. Hematologic: Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hemoglobinopathy, anemia, or any other traits known to interfere with measurement of HbA1c
15. Have presence of clinically significant gastrointestinal disease (for example, clinically active gastroparesis associated with wide glucose fluctuations) in the investigator’s opinion
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence (percentage of subjects with at least 1 event) and rate (events/subject/year) of all documented hypoglycemia (BG<54 mg/dL)
From baseline through Week 26
Secondary Outcome
Outcome
TimePoints
1. SAEs and TEAEs
2. Incidence and rate (events/subject/year) of severe hypoglycemic events
3. Incidence and rate (events/subject/year) of nocturnal hypoglycemia (BG<54 mg/dL)
4. Incidence and rate (events/subject/year) of nocturnal and all documented hypoglycemic events (BG<70 mg/dL)
5. Change in body weight
6. Change in ITSQ scores
1. From baseline through study followup
2. From baseline through Week 26
3. From baseline through Week 26
4. From baseline through Week 26
5. From baseline to Week 26
6. From baseline to Week 26
Target Sample Size
Total Sample Size="150" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "150" Final Enrollment numbers achieved (India)="150"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
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).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
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.
For what types of analyses will this data be available? Response - For individual participant data meta-analysis.
By what mechanism will data be made available? Response (Others) - www.vivli.org
For how long will this data be available start date provided 01-01-2024 and end date provided 30-06-2024? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
Lyumjev® received marketing approval in India on 06 July 2021 for the treatment of adults with type 2 diabetes mellitus (T2DM) 18 years or older.
The aim of this study is to evaluate the safety of Lyumjev, as measured by incidence and rate of documented hypoglycemia from baseline to Week 26 in subjects with T2DM, when administered as a multiple daily injection (MDI) regimen in combination with basal insulin glargine 100 U/mL pen (Basaglar®).
Results of this study will satisfy the request from Drug Controller General of India to provide safety and efficacy data in a minimum of 100 additional Indian subjects.