Safety and Efficacy of Exenatide Injection in Subjects With Type 2 Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Sun Pharmaceutical Industries Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT01406717
First received: July 28, 2011
Last updated: November 14, 2013
Last verified: September 2012
  Purpose

Exenatide is the first in a new class of drugs for the treatment of type 2 diabetes mellitus called incretin mimetics. Exenatide resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of exenatide injection which will be supplied in the form of a reusable pen with cartridge containing exenatide for self administration.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide, Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Exenatide Injection in Subjects With Type 2 Diabetes Mellitus: a Randomized, Double Blind, Placebo-controlled, Parallel Groups, Multicentric, 24-week Trial

Resource links provided by NLM:


Further study details as provided by Sun Pharmaceutical Industries Limited:

Primary Outcome Measures:
  • Proportion of subjects positive for anti-exenatide antibodies. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of potentially immune-related treatment-emergent adverse events will be evaluated. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigator's global impression of change. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Investigator's global impression of change will be recorded at end of trial or premature trial termination visit on a scale of 1-7 as follows:

    Scale: Overall impression

    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse

  • Shifts in vital signs and other laboratory safety parameters from baseline to end-of-trial. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Other (non-immune-related) treatment-emergent adverse events will be evaluated. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Subject's global impression of change [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Subject's global impression of change will be recorded at end of trial or premature trial termination visit on a scale of 1-7 as follows:

    Scale: Overall impression

    1. Very much improved
    2. Much improved
    3. Minimally improved
    4. No change
    5. Minimally worse
    6. Much worse
    7. Very much worse


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide injection Drug: Exenatide, Placebo
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily in the thigh, abdomen, or upper arm within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).
Placebo Comparator: Placebo Drug: Exenatide, Placebo
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily in the thigh, abdomen, or upper arm within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).

Detailed Description:

Exenatide subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

In this randomized, double blind, placebo controlled, parallel groups, multi-centric, 24-week trial, anti-exenatide antibody generation after administration of exenatide injection versus placebo and its impact on efficacy and safety will be evaluated. Subjects will receive exenatide or placebo injection 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. Injection is to be self-administered with a pen injector subcutaneously twice daily in the thigh, abdomen, or upper arm within the 60-minute period before the morning and evening meals (or before the two main meals of the day) at least 6 hours apart.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 20 years of age and older.
  • Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
  • Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
  • Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
  • Willing to participate and give written informed consent.

Exclusion Criteria:

  • Previous exposure to exenatide (anti-exenatide antibodies at screening) or a GLP-1 analogue.
  • Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
  • Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
  • Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406717

Contacts
Contact: Shravanti Bhowmik, MD 91 22 66455645 ext Direct shravanti.bhowmik@sparcmail.com

Locations
India
Osmania General Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500012
Contact: Rakesh Sahay    040-2460-0124    sahayrk@gmail.com   
Medwin Hospitals Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500001
Contact: Kirtikumar Modi    91-40-23202902    drkdmodi@yahoo.co.in   
Apollo Hospitals Not yet recruiting
Hyderabad, Andhra Pradesh, India, 50009
Contact: Shreekanth Jaganmani    040-23607777    drjsreekanth@gmail.com   
King George Hospital Not yet recruiting
Vishakhapatnam, Andhra Pradesh, India, 530002
Contact: K A V Subrahmanium    9848149536    kavsendo@yahoo.co.in   
Medlink Hospital Not yet recruiting
Ahmedabad, Gujrat, India
Contact: Manish Agrawal    07926761715    medilinkresearchcentre@yahoo.com   
Ramananda Clinic Recruiting
Ahmedabad, Gujrat, India, 380001
Contact: V K Abichandani    079-25506219    vkabichandani@yahoo.co.in   
Vijayratna Diabetes Diagnosis and Treatment Centre Not yet recruiting
Ahmedabad, Gujrat, India, 380014
Contact: Sanjeev Pathak    07926640339    sanjeevpathak@hotmai.com   
Pruthvi Medical Nursing Home & Heart Centre Recruiting
Ahmedabad, Gujrat, India, 380014
Contact: Jitendra Patel    079-27681249    pruthvi_jitendra@hotmail.com   
Dr Jay Karnani's Clinic Recruiting
Ahmedabad, Gujrat, India, 380009
Contact: Jay Karnani    07926560926    Jkarnani@indiatimes.com   
Kusum Medical Nursing Home Recruiting
Rajkot, Gujrat, India, 360001
Contact: V S Chandarana, M.Sc.    2812445997    drvijaykusum@yahoo.co.in   
saurashtra Diabetes Clinic Recruiting
Rajkot, Gujrat, India, 360002
Contact: Vidyut Shah    0281-2232819    shah_vidyut@yahoo.co.in   
Sonal Hospital and Diabetes Center Recruiting
Surat, Gujrat, India, 395003
Contact: Jashvant Shah    0261-242238    drjlshah@yahoo.com   
Sanjivani Hospital and ICCU Centre Recruiting
Surat, Gujrat, India, 395001
Contact: Dhiren Patel    0261 2238600    pateldrdhiren@hotmail.com   
Arihant Clinic Recruiting
Surat, Gujrat, India, 395002
Contact: Manish Singhavi    02612231635    drmanishrsinghavi@gmail.com   
Shreeji Hospital Recruiting
Surat, Gujrat, India, 395006
Contact: Purushottam Koradia    Phone:9979530073    nimish.dudhatra@gmail.com   
Krishnashray Hospital Recruiting
Vadodara, Gujrat, India, 390001
Contact: Bipin Shah    0265- 2412600    drbipinshah@ymail.com   
Bangalore Diabetes Hospital Not yet recruiting
Bangalore, Karnataka, India, 56 0052
Contact: Prasanna Kumar    8022372980    dr.kmpk@gmail.com   
BGS Global Hospitals Not yet recruiting
Bangalore, Karnataka, India, 560060
Contact: Satish Babu    080-49067192    babu09_uk@yahoo.co.uk   
Manipal Hospital Not yet recruiting
Bangalore, kARNATAKA, India, 560017
Contact: Manohar K N    8025456616    drmanohar_kn@yahoo.com   
Kasturba Hospital Not yet recruiting
Manipal, Karnataka, India, 576104
Contact: Sudha Vidyasagar    9880083580    vsagar33@yahoo.com   
Diabetes Care and Research Centre Pvt. Ltd., Recruiting
Nagpur, Maharashtra, India, 440010
Contact: Sunil Gupta    0712-2428222    drsgupta_ngp@rediffmail.com   
Getwell Hospital and Research Institute Not yet recruiting
Nagpur, Maharashtra, India, 0712-6632200
Contact: Jayashree Shembhalkar    0712-6632200    pkshembalkar@gmail.com   
Prasad Clinic Not yet recruiting
Nashik, Maharashtra, India, 422005
Contact: Pankaj Rane    02532099794    dr.pankajrane@yahoo.com   
Deenanath Mangeshkar Hospital & Reseach Centre Not yet recruiting
Pune, Maharashtra, India, 411004
Contact: Vaishali Deshmukh, MD    020-40151666    researchchetando@gmail.com   
Ira Clinic Recruiting
Pune, Maharashtra, India, 411004
Contact: Mohan Magdum, MD    020-25512131    mohanmagdum@gmail.com   
Principal Investigator: Mohan a Magdum         
Pai Clinic and Diagnostic Centre Not yet recruiting
Pune, Maharashtra, India, 11005
Contact: Vikas V Pai, MBBS    91-20-25534404    drpaivikas@gmail.com   
Principal Investigator: Vikas G Pai, MD         
KEM Hospital and research center Not yet recruiting
Pune, Maharashtra, India, 411011
Contact: C Yajnik    26111958    diabetestrials@yahoo.com   
Kanungo Institute of Diabetes Specialities Pvt. Ltd Not yet recruiting
Bhubaneshwar, Orrissa, India, 751019
Contact: Alok Kanungo    0674-2471300    kanungokids@gmail.com   
Dayanand Medical College and Hospital Not yet recruiting
Ludhiana, Punjab, India
Contact: Parminder Singh    09814077536    Pam.endo@yahoo.co.in   
S. R. Kalla Memorial Gastro & General Hospital Not yet recruiting
Jaipur, Rajasthan, India, 302001
Contact: Jugal Gupta    91-141-5112042    drjbgupta@gmail.com   
Diabetes, Thyroid and Endocrine Centre Not yet recruiting
Jaipur, Rajasthan, India, 302006
Contact: Surendra Sharma    0141-2229202    sksharma7@gmail.com   
Shri Ramachandra Medical College & Research Institute Not yet recruiting
Chennai, Tamilnadu, India, 600116
Contact: Krishnan Sheshadri    0261 2238600    pateldrdhiren@hotmail.com   
G. Kuppuswamy Naidu Memorial Hospital Not yet recruiting
Coimbatore, Tamilnadu, India, 641037
Contact: R Srinivasan    9600933080    srinir02@gmail.com   
Kovai Diabetes Speciality Center and Hospital Not yet recruiting
Coimbatuore, Tamilnadu, India, 641009
Contact: Balamurugan    9842244881    Balamurugan_dr@hotmail.com   
Arthur Asirvatham Hospital Recruiting
Madurai, Tamilnadu, India, 625020
Contact: Arthur Asirvatham    0452-2531977    drajasirvatham@yahoo.com   
King Georges Medical College Not yet recruiting
Lucknow, Uttar Pradesh, India, 226003
Contact: D Himanshu    5222258948    dr.himanshu.reddy@gmail.com   
M.V. Hospital & Research Centre Not yet recruiting
Lucknow, Uttar Pradesh, India, 226003
Contact: Sandeep Gupta    0522-3238446    sandeepkumar.gupta@rediffmail.com   
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Company Limited
  More Information

No publications provided

Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT01406717     History of Changes
Other Study ID Numbers: CLR_10_33
Study First Received: July 28, 2011
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by Sun Pharmaceutical Industries Limited:
Exenatide, type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014