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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT01406717
First received: July 28, 2011
Last updated: October 20, 2015
Last verified: October 2015
  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: December 2015
Estimated Primary Completion Date: December 2015 (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   (Adult, Senior)
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

Locations
India
Medwin Hospitals
Hyderabad, Andhra Pradesh, India, 500001
Osmania General Hospital
Hyderabad, Andhra Pradesh, India, 500012
Apollo Hospitals
Hyderabad, Andhra Pradesh, India, 500096
King George Hospital
Vishakhapatnam, Andhra Pradesh, India, 530002
Ramananda Clinic
Ahmedabad, Gujrat, India, 380001
Dr Jay Karnani's Clinic
Ahmedabad, Gujrat, India, 380009
Pruthvi Medical Nursing Home & Heart Centre
Ahmedabad, Gujrat, India, 380014
saurashtra Diabetes Clinic
Rajkot, Gujrat, India, 360002
Sanjivani Hospital and ICU Centre
Surat, Gujrat, India, 395001
Arihant Clinic
Surat, Gujrat, India, 395002
Sonal Hospital and Diabetes Center
Surat, Gujrat, India, 395003
Shreeji Hospital
Surat, Gujrat, India, 395006
Krishnashray Hospital
Vadodara, Gujrat, India, 390001
Bangalore Diabetes Centre
Bangalore, Karnataka, India, 56 0043
Manipal Hospital
Bangalore, kARNATAKA, India, 560017
St. John's Medical college and Hospital
Bangalore, Karnataka, India, 560034
BGS Global Hospitals
Bangalore, Karnataka, India, 560060
Kasturba Hospital
Manipal, Karnataka, India, 576104
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India, 452010
Diabetes Care and Research Centre Pvt. Ltd.,
Nagpur, Maharashtra, India, 440010
Getwell Hospital and Research Institute
Nagpur, Maharashtra, India, 440012
Shreyas Hospital
Nashik, Maharashtra, India, 422009
Ira Clinic
Pune, Maharashtra, India, 411004
Pai Clinic and Diagnostic Centre
Pune, Maharashtra, India, 411005
Kanungo Institute of Diabetes Specialities Pvt. Ltd
Bhubaneshwar, Orrissa, India, 751019
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India, 302001
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India, 302006
Christian Medical College Hospital
Vellore, Tamil Nadu, India, 632004
Shri Ramachandra Medical College & Research Institute
Chennai, Tamilnadu, India, 600116
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamilnadu, India, 641009
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamilnadu, India, 641037
Arthur Asirvatham Hospital
Madurai, Tamilnadu, India, 625020
King Georges Medical University
Lucknow, Uttar Pradesh, India, 226003
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, India, 226003
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Company Limited
  More Information

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: October 20, 2015
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 24, 2016