Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT01406717
First received: July 28, 2011
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
SPIL1033 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 SPIL1033

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: SPIL1033, 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 SPIL1033 in Subjects With Type 2 Diabetes Mellitus

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
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPIL1033 Drug: SPIL1033, 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.
Placebo Comparator: Placebo Drug: SPIL1033, 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.

Detailed Description:

SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.

In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.

  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
SPIL Site 22
Hyderabad, Andhra Pradesh, India
SPIL Site 25
Hyderabad, Andhra Pradesh, India
SPIL Site 26
Hyderabad, Andhra Pradesh, India
SPIL Site 23
Vishakhapatnam, Andhra Pradesh, India
SPIL Site 1
Ahmedabad, Gujrat, India
SPIL Site 2
Ahmedabad, Gujrat, India
SPIL Site 3
Ahmedabad, Gujrat, India
SPIL Site 5
Rajkot, Gujrat, India
SPIL Site 6
Surat, Gujrat, India
SPIL Site 7
Surat, Gujrat, India
SPIL Site 8
Surat, Gujrat, India
SPIL Site 9
Surat, Gujrat, India
SPIL Site 10
Vadodara, Gujrat, India
SPIL Site 19
Bangalore, kARNATAKA, India
SPIL Site 30
Bangalore, Karnataka, India
SPIL Site 31
Bangalore, Karnataka, India
SPIL Site 33
Bangalore, Karnataka, India
SPIL Site 29
Manipal, Karnataka, India
SPIL Site 35
Indore, Madhya Pradesh, India
SPIL Site 21
Nagpur, Maharashtra, India
SPIL Site 24
Nagpur, Maharashtra, India
SPIL Site 32
Nashik, Maharashtra, India
SPIL Site 11
Pune, Maharashtra, India
SPIL Site 12
Pune, Maharashtra, India
SPIL Site 13
Bhubaneshwar, Orrissa, India
SPIL Site 14
Jaipur, Rajasthan, India
SPIL Site 15
Jaipur, Rajasthan, India
SPIL Site 34
Vellore, Tamil Nadu, India
SPIL Site 16
Chennai, Tamilnadu, India
SPIL Site 17
Coimbatore, Tamilnadu, India
SPIL Site 20
Coimbatore, Tamilnadu, India
SPIL Site 18
Madurai, Tamilnadu, India, 625020
SPIL Site 27
Lucknow, Uttar Pradesh, India
SPIL Site 28
Lucknow, Uttar Pradesh, India
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: September 30, 2016
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by Sun Pharmaceutical Industries Limited:
SPIL1033
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 08, 2016