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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SPIL1033; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406717

CLR_10_33

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 360 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 2 patient groups, including a placebo group

SPIL1033

Experimental group

Treatment:

Drug: SPIL1033

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo