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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
SPIL Site 22
Hyderabad, Andhra Pradesh, India
Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
Time frame: 24 weeks
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
Time frame: 24 weeks
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
Time frame: 24 weeks
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
Time frame: 24 weeks
Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
Time frame: 24 weeks
Change From Baseline in Triglycerides
Time frame: 24 weeks
Change From Baseline in Low Density Lipoproteins
Time frame: 24 weeks
Change From Baseline in High Density Lipoproteins
Time frame: 24 weeks
Change in Body Weight
Time frame: 24 weeks
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
Time frame: 24 weeks
Change From Baseline in Very Low Density Lipoproteins
Time frame: 24 weeks
Change From Baseline in Total Cholesterol
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SPIL Site 25
Hyderabad, Andhra Pradesh, India
SPIL Site 26
Hyderabad, Andhra Pradesh, India
SPIL Site 23
Visakhapatnam, Andhra Pradesh, India
SPIL Site 1
Ahmedabad, Gujarat, India
SPIL Site 2
Ahmedabad, Gujarat, India
SPIL Site 3
Ahmedabad, Gujarat, India
SPIL Site 5
Rajkot, Gujarat, India
SPIL Site 6
Surat, Gujarat, India
SPIL Site 7
Surat, Gujarat, India
...and 24 more locations
Time frame: 24 weeks