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

• Status: Completed
• Trial end date: 2015-11-04
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited

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 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.