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

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.

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 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.