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

July 28, 2011
September 30, 2016
January 2013
November 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01406717 on ClinicalTrials.gov Archive Site
  • 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
  • Investigator's global impression of change and subject's global impression of change. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Investigator's global impression of change and 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
  • 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 ]
Not Provided
Not Provided
 
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
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.
  • Experimental: SPIL1033
    Intervention: Drug: SPIL1033, Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: SPIL1033, Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01406717
CLR_10_33
No
Not Provided
Not Provided
Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited
Not Provided
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Company Limited
Sun Pharmaceutical Industries Limited
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP