| CTRI Number |
CTRI/2015/02/005536 [Registered on: 12/02/2015] Trial Registered Prospectively |
| Last Modified On: |
14/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare long acting basal insulin analog to lantus in adult patients with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients with Type 2 Diabetes Mellitus: the ELEMENT 5 Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| I4L-MC-ABER dated 28-Aug-2014 |
Protocol Number |
| NCT02302716 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Tarun Puri |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company India Private Limited |
| Address |
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32,Gurgaon.
Gurgaon
HARYANA
122001
India |
| Phone |
01244753000 |
| Fax |
01244753013 |
| Email |
puri_tarun@lilly.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Tarun Puri |
| Designation |
Medical Director |
| Affiliation |
Eli Lilly and Company India Private Limited |
| Address |
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32,Gurgaon.
Gurgaon
HARYANA
122001
India |
| Phone |
01244753000 |
| Fax |
01244753013 |
| Email |
puri_tarun@lilly.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeev Sharan Shrivastava |
| Designation |
Director-Clinical Research |
| Affiliation |
Eli Lilly and Company India Private Limited |
| Address |
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32,Gurgaon.
Gurgaon
HARYANA
122001
India |
| Phone |
01244753000 |
| Fax |
01244753013 |
| Email |
shrivastava_rajeev_sharan@lilly.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eli Lilly and Company |
| Address |
Corporate Center Indianapolis, IN 46285 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Russian Federation
Taiwan
Turkey
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kartikeya Parmar |
B.J. Medical College and Civil hospital |
Department of Medicine, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT |
919924643799
07922683421
drkartik@gmail.com |
| Dr Mazher Ali |
Care Hospital |
Department of Endocrinology, Care Outpatient Centre, 8-2-620/ A-E, Road No 10, Banjara Hills, 500034, Hyderabad, Telengana
Hyderabad
ANDHRA PRADESH |
9440365585
04066258792
mazherali@gmail.com |
| Dr Viswanathan Mohan |
Dr. Mohans Diabetes Specialities Centre and MDRF |
Department of Endocrinology, MDRF, 6B, Conran smith Road, Gopalpuram, Chennai-600086
Chennai
TAMIL NADU |
9840097370
914428350935
drmohans@diabetes.ind.in |
| Dr Jugal Bihari Gupta |
Eternal Heart Care Centre and Research Institute |
3A, Jagatpura Road, Near Jawahar Circle, Jaipur, Rajasthan - 302020
Jaipur
RAJASTHAN |
9829414680
drjbgupta@gmail.com |
| Dr Vijay Shekhar Reddy |
Gandhi Hospital |
Department of Endocrinology, Musheerabad, Secunderabad, Telengana, 500003
Hyderabad
ANDHRA PRADESH |
9849172161
04027504441
drdvsreddyendo@yahoo.com |
| Dr Nalini Shah |
Global Hospitals |
Department of Endocrinology 35, D.E.Borges Road, Hospital Avenue
Opp Shirodkar High school,
Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9820025037
9102267670101
nalinishah@gmail.com |
| Dr Parag Shah |
Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre |
Department of Endocrinology, Ratubhai Adani Arogyadham, Dr. Jivraj Mehta Marg, Near Ayojan Nagar, Ahmedabad -380007
Ahmadabad
GUJARAT |
919824042688
07926639839
paragendocrine@yahoo.com |
| Dr Kandregula Appala Venkata Subrahmanyam |
King George Hospital |
New Multispeciality Block, Department of Endocrinology, Maharanipeta, Vishakhapatnam,AP 530002
Visakhapatnam
ANDHRA PRADESH |
9848149536
08912711879
kavsendo@yahoo.co.in |
| Dr Sameer Yadav |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Internal Medicine, Dr. Ambedkar Road, Sion, Mumbai 400022
Mumbai
MAHARASHTRA |
9820845712
912224074624
sameer_yadav25@yahoo.com |
| Dr Rakesh Sahay |
Osmania General Hospital |
Department of Endocrinology, 2nd floor, Golden Jubilee Block, Afzalganj, Hyderabad-500012 Telengana
Hyderabad
ANDHRA PRADESH |
9849597507
04024651667
sahayrk@gmail.com |
| Dr Manoj Chadha |
P. D. Hinduja National Hospital and Medical Research Centre |
Department of Endocrinology, Veer Sarvarkar Marg, Mahim, Mumbai, 400016
Mumbai
MAHARASHTRA |
9821548346
912224449199
mchadha59@gmail.com |
| Dr Abhay Mutha |
Ruby Hall Clinic |
40, Sasoon Road, B S Dhole Patil Path, Pune, 411001
Pune
MAHARASHTRA |
9823037900
9120266455631
drabhaymutha@gmail.com |
| Dr Sudhir Tripathi |
Sir Ganga Ram Hospital |
Department of Endocrinology and Metabolism ,Rajinder Nagar, New delhi 110060
New Delhi
DELHI |
919811126165
01142437230
sudhirtrip@gmail.com |
| Dr Vageesh Ayyar |
St. Johns Medical College and Hospital |
Department of Endocrinology, Sarjapur Rd, Koramangala, Bangalore-560034
Bangalore
KARNATAKA |
8022065649
918025635313
vagayyar@gmail.com |
| Dr Premlata Varthakavi |
Topiwala National Medical College & BYL Nair Ch. Hospital |
Department of Endocrinology, Dr. A. L. Nair Road, Mumbai Central, 400008
Mumbai
MAHARASHTRA |
9224480560
912223080601
premavar@hotmail.com |
| Dr Minguel Rufino Monteiro |
Vintage Hospital and Medical Research Center Pvt. Ltd. |
Department of Medicine, Caculo Enclave, St. Inez, Panjim, Goa 403001
North Goa
GOA |
08326711541
08326644406
dr.rufinomonteiro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Eternal Heart Care Centre and Research Institute - Institutional Ethics Committee |
Approved |
| Ethics Committee, Global Hospital |
Approved |
| Ethics Committee, Osmania Medical College |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee, B J Medical College and Civil Hospital |
Approved |
| Institutional Ethics Committee, Care Hospital |
Approved |
| Institutional Ethics Committee, Gandhi Hospital |
Approved |
| Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College |
Approved |
| Institutional Ethics Committee, P.D. Hinduja National Hospital and Medical Research Centre |
Approved |
| Institutional Ethics Committee, Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, TNM Medical College & BYL Nair Ch. Hospital |
Approved |
| Instiutional Ethics Committee, King George Hospital |
Approved |
| St John’s Medical College & Hospital Institutional Ethics Committee |
Approved |
| The JMSHF and BMRC Institutional Ethics Committee |
Approved |
| Vintage Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LANTUS® |
Insulin naive participants started on 10 U LANTUS® given SC QD for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or NPH QD will be started at the same dose SC. Participants entering on insulin detemir or NPH twice a day will be started at 80 percent of the total daily dose SC. Participants will self titrate LANTUS® based on FBG. Participants will continue OAM. |
| Intervention |
LY2963016 |
Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants entering the study on LANTUS®, insulin detemir or neutral protamine hagedorn (NPH) QD will begin the study at their current dose SC. Participants will self titrate LY2963016 based on fasting blood glucose (FBG). Participants entering on insulin detemir or NPH twice a day will be started at 80 percent of the total daily dose SC. Participants will continue oral antihyperglycemic medication (OAM). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Have type 2 diabetes mellitus (T2DM).
-Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening, with or without basal insulin.
-If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry.
-Have an HbA1c ≥7.0% and ≤11.0% if insulin naïve; if previously on basal insulin, then HbA1c ≤11.0%.
-Body mass index (BMI) ≤45 kilograms per meter squared (kg/m2).
-As determined by the investigator, are capable and willing to do the following:
Perform self monitored blood glucose (SMBG)
Complete participant diaries as instructed
Are receptive to diabetes education
Comply with required study treatment and study visits
|
|
| ExclusionCriteria |
| Details |
-Have been on LANTUS® more than once daily within the previous 30 days.
-Have used any other insulin except the entry insulin [LANTUS®, insulin detemir, or NPH] including commercial (includes any premixed insulins) and investigational insulins within the previous 30 days.
-Have been exposed to a biosimilar insulin glargine within the previous 90 days.
-Have participated in a LY2963016 study.
-Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than 4 continuous weeks.
-Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
-Have used pramlintide within the previous 30 days.
-Have excessive insulin resistance at study entry (total insulin dose ≥1.5 units/kg).
-Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.
-Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
-Have known hypersensitivity or allergy to LANTUS® or its excipients.
-Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately preceding screening.
-Have obvious signs or symptoms, or laboratory evidence, of liver disease.
-Have one of the following concomitant diseases: significant cardiac (e.g., congestive heart failure Class III or IV) or gastrointestinal disease (e.g., significant gastroparesis).
-Have a history of renal transplantation or are currently receiving renal dialysis.
-Have a serum creatinine greater than 2.0 milligrams/deciliter (177 micromoles/liter).
-Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
-Participants with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
-Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.
-Have any other condition (including known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol.
-Are pregnant or intend to become pregnant during the course of the study.
-Women who are breastfeeding.
-Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device other than LY2963016, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c) |
Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of Participants With HbA1c 7% and ≤6.5% |
Time Frame: Baseline and Week 24 |
| Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values |
Time Frame: Baseline and Week 24 |
| Intra-Participant Variability in FBG |
Time Frame: Baseline and Week 24 |
| Basal Insulin Dose |
Time Frame: Baseline and Week 24 |
| Change from Baseline to 24 Weeks in Body Weight |
Time Frame: Baseline, 24 Weeks |
| Insulin Treatment Satisfaction Questionnaire (ITSQ) |
Time Frame: Week 4 and Week 24 |
| Proportion of Participants with Detectable Anti-Drug Antibodies to LY2963016 or LANTUS® |
Time Frame: Baseline through Week 24 |
| Rate of Hypoglycemic Events Adjusted per 30 Days |
Time Frame: Baseline through Week 24 |
| Percentage of Participants with Hypoglycemic Events |
Time Frame: Baseline through Week 24 |
|
|
Target Sample Size
|
Total Sample Size="492"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/12/2014 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="26" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs). |