Status:
COMPLETED
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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
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 eva...
Eligibility Criteria
Inclusion
- 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
- Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01406717
Start Date
March 1 2013
End Date
November 4 2015
Last Update
August 11 2020
Active Locations (34)
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1
SPIL Site 22
Hyderabad, Andhra Pradesh, India
2
SPIL Site 25
Hyderabad, Andhra Pradesh, India
3
SPIL Site 26
Hyderabad, Andhra Pradesh, India
4
SPIL Site 23
Visakhapatnam, Andhra Pradesh, India