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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: SPIL1033
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIL1033<br> | Drug: SPIL1033<br>* 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study in Hemoglobin A1c (HbA1c) |  | 24 weeks | 
| Change From Baseline to End of Study in Fasting Plasma Glucose (FPG) |  | 24 weeks | 
| Count and Percentage of Subjects Positive for Anti-exenatide Antibodies |  | 24 weeks | 
| Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 2hour Postprandial Glucose (2-h PPG) |  | 24 weeks | 
| Change From Baseline in Triglycerides |  | 24 weeks | 
| Change From Baseline in Low Density Lipoproteins |  | 24 weeks | 
| Change From Baseline in High Density Lipoproteins |  | 24 weeks | 
| Change in Body Weight |  | 24 weeks | 
| Subjects Achieving Hemoglobin A1c (HbA1c) < 7% |  | 24 weeks | 
| Change From Baseline in Very Low Density Lipoproteins |  | 24 weeks | 
| Change From Baseline in Total Cholesterol |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPIL1033, type 2 diabetes mellitus