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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: SPIL1033; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India
      • SPIL Site 22
    • Hyderabad, Andhra Pradesh, India
      • SPIL Site 25
    • Hyderabad, Andhra Pradesh, India
      • SPIL Site 26
    • Visakhapatnam, Andhra Pradesh, India
      • SPIL Site 23
  • Gujrat
    • Ahmedabad, Gujrat, India
      • SPIL Site 1
    • Ahmedabad, Gujrat, India
      • SPIL Site 2
    • Ahmedabad, Gujrat, India
      • SPIL Site 3
    • Rajkot, Gujrat, India
      • SPIL Site 5
    • Surat, Gujrat, India
      • SPIL Site 6
    • Surat, Gujrat, India
      • SPIL Site 7
    • Surat, Gujrat, India
      • SPIL Site 8
    • Surat, Gujrat, India
      • SPIL Site 9
    • Vadodara, Gujrat, India
      • SPIL Site 10
  • Karnataka
    • Bangalore, Karnataka, India
      • SPIL Site 30
    • Bangalore, Karnataka, India
      • SPIL Site 31
    • Bangalore, Karnataka, India
      • SPIL Site 33
    • Manipal, Karnataka, India
      • SPIL Site 29
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India
      • SPIL Site 35
  • Maharashtra
    • Nagpur, Maharashtra, India
      • SPIL Site 21
    • Nagpur, Maharashtra, India
      • SPIL Site 24
    • Nashik, Maharashtra, India
      • SPIL Site 32
    • Pune, Maharashtra, India
      • SPIL Site 11
    • Pune, Maharashtra, India
      • SPIL Site 12
  • Orrissa
    • Bhubaneshwar, Orrissa, India
      • SPIL Site 13
  • Rajasthan
    • Jaipur, Rajasthan, India
      • SPIL Site 14
    • Jaipur, Rajasthan, India
      • SPIL Site 15
  • Tamil Nadu
    • Vellore, Tamil Nadu, India
      • SPIL Site 34
  • Tamilnadu
    • Chennai, Tamilnadu, India
      • SPIL Site 16
    • Coimbatore, Tamilnadu, India
      • SPIL Site 17
    • Coimbatore, Tamilnadu, India
      • SPIL Site 20
    • Madurai, Tamilnadu, India, 625020
      • SPIL Site 18
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India
      • SPIL Site 27
    • Lucknow, Uttar Pradesh, India
      • SPIL Site 28
  • kARNATAKA
    • Bangalore, kARNATAKA, India
      • SPIL Site 19

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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.
Experimental: SPIL1033	Drug: SPIL1033; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): November 4, 2015
• Study Completion (Actual): November 4, 2015

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; SPIL1033
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CLR_10_33