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CTRI Number  CTRI/2012/01/002337 [Registered on: 13/01/2012] Trial Registered Prospectively
Last Modified On: 13/05/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Efficacy of Exenatide in Adolescents with Type 2 Diabetes  
Scientific Title of Study   Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
H8O-MC-GWBQ  Protocol Number 
NCT00658021  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sedat Altug 
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  0124-4753000  
Fax  0124-4753013  
Email  altug_sedat@lilly.com  
 
Details of Contact Person
Scientific Query  
Name  Sedat Altug 
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


HARYANA
122001
India 
Phone  0124-4753000  
Fax  0124-4753013  
Email  altug_sedat@lilly.com  
 
Details of Contact Person
Public Query  
Name  Anil Seth 
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  0124-4753000  
Fax  0124-4753013  
Email  seth_anil@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company 
 
Primary Sponsor  
Name  Eli Lilly and Company 
Address  Corporate Center Indianapolis, IN 46285 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Mexico
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kankatte Prassanna Kumar  Bangalore Diabetes Hospital  Department of Medicine,16/M Miller’s Tank Road Bed Area, Thimmiah Road, Vasanth Nagar
Bangalore
KARNATAKA 		 080-22372980
080-22372981
prassnnaa@gmail.com 
Dr Mala Dharmalingam  Bangalore Endocrinology and Diabetes Research Center Pvt. Ltd.  No 35, 5th Cross, Malleshwaram Circle,
Bangalore
KARNATAKA 		 09845208163
080-41281998
bedrc1@gmail.com 
Dr Abhay Mutha  Diabetes Care & Research Centre  Department of Medicine, B-5, Mittal Court, 478, Rathapeth
Pune
MAHARASHTRA 		 09823037900
020-26124232
drabhaymutha@gmail.com 
Dr Parag Shah  Gujarat Endocrine Center  Department of Medicine, 201 Silver Brook-B,opp.Doctor House, Ellisbridge
Ahmadabad
GUJARAT 		 079-26444222
079-26461316
krishnapatel73@hotmail.com 
Dr Vaman Khadilkar  Jehangir Hospital  Department of Endocrinology, 32 Sasson Road
Pune
MAHARASHTRA 		 020-26137617
020-26059319
vamankhadilkar@gmail.com 
Dr Rakesh Sahay  Osmania General Hospital  2nd Floor, Golden Jubilee Block, Afzalgunj
Hyderabad
ANDHRA PRADESH 		 09849597507
040-24651667
sahayrk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bangalore Diabetes Hospital  Approved 
BEDRC Ethics Committee on Human Research  Approved 
Diabetes Care and Research Center  Approved 
Gujrat Kidney Foundation Ethics Committee  Approved 
Jehangir Clinical Development Centre Ethics Committee  Approved 
Osmania Medical College  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adolescents With Type 2 Diabetes ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exenatide 10 mcg arm  Subcutaneous injection, twice a day, 5 mcg for 4 weeks followed by 10 mcg twice a day for 24 weeks 
Intervention  Exenatide 5 mcg arm  Subcutaneous injection, twice a day, 5 mcg for 28 weeks 
Comparator Agent  Placebo   Subcutaneous injection, twice a day for 28 weeks 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  -Are between ages 10 to 17 years, inclusive.
-Have a history of type 2 diabetes.
-Have no antibodies to glutamic decarboxylase (GAD65) or islet cell (ICA512).
-Have been treated with Met, an SU, or both Met and SU (with or without diet and exercise), for at least 3 months or are naïve to antidiabetic agents (with diet and exercise). The dose of oral agent(s) should be stable for the 30 days prior to the screening visit.
-Have HbA1c between 6.5% and 10.5%, inclusive.
-Present an appropriately signed assent form.
-A parent or adult guardian agrees in writing to participate in the patient(s) treatment by signing a consent form.
-Both the patient and parent or responsible adult guardian are able to understand and comply with a lifestyle modification program.
 
 
ExclusionCriteria 
Details  -Received any investigational drug or has participated in any type of clinical trial within 60 days prior to screening.
-Have previously been exposed to exenatide or, completed or withdrawn from any study investigating exenatide.
-Are unwilling or unable to inject the study medication.
-Have a genetic syndrome or disorder other than diabetes known to affect glucose tolerance.
-Have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for more than 1 week during the 3 months prior to screening.
-Currently use inhaled steroids at a dose equal to or above 1000 μg Flovent® (fluticasone propionate) daily.
-Have used oral steroids within the last 60 days or more than 20 days use within the past year.
-Have used a TZD within 120 days prior to screening.
-Have used any weight loss medication(s) within 30 days of screening.
-Are sexually active female of childbearing potential who is unwilling to appropriately use TWO methods of birth control (for example, use of oral contraceptives; condoms with contraceptive foam; or abstinence) for the duration of the study.
-Are female who is pregnant or planning to become pregnant within 6 months of study screening.
-Are female who is lactating.
-Have had at least one episode of diabetic ketoacidosis (DKA) after receiving antidiabetes medication. A history of DKA at the time of diagnosis will not be an exclusion criterion.
-Have physical limitations that prevent participation in lifestyle intervention.
-Have admitted use of anabolic steroids within the past 60 days.
-Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than in situ carcinomas of the cervix) for less than 5 years.
-Have used insulin for more than 10 weeks during the 3 months prior to screening.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients   28 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Exenatide 5 µg BID vs. Exenatide 10 µg BID vs. placebo to compare: the proportion of patients achieving an HbA1c at endpoint of ≤7%, 7%, ≤6.5% and 6.5% • body weight • fasting serum glucose.  28 Weeks 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/02/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  30/05/2008 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="6"
Months="3"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetic agents(with diet and exercise) or who are being treated with Met, SU, or a combination of Met and SU (with or without diet and exercise).

 
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