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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
SPIL1033
Placebo
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring SPIL1033, type 2 diabetes mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • SPIL Site 22
  • SPIL Site 25
  • SPIL Site 26
  • SPIL Site 23
  • SPIL Site 1
  • SPIL Site 2
  • SPIL Site 3
  • SPIL Site 5
  • SPIL Site 6
  • SPIL Site 7
  • SPIL Site 8
  • SPIL Site 9
  • SPIL Site 10
  • SPIL Site 19
  • SPIL Site 30
  • SPIL Site 31
  • SPIL Site 33
  • SPIL Site 29
  • SPIL Site 35
  • SPIL Site 21
  • SPIL Site 24
  • SPIL Site 32
  • SPIL Site 11
  • SPIL Site 12
  • SPIL Site 13
  • SPIL Site 14
  • SPIL Site 15
  • SPIL Site 34
  • SPIL Site 16
  • SPIL Site 17
  • SPIL Site 20
  • SPIL Site 18
  • SPIL Site 27
  • SPIL Site 28

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SPIL1033

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
Change From Baseline in Triglycerides
Change From Baseline in Low Density Lipoproteins
Change From Baseline in High Density Lipoproteins
Change in Body Weight
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
Change From Baseline in Very Low Density Lipoproteins
Change From Baseline in Total Cholesterol

Full Information

First Posted
July 28, 2011
Last Updated
July 29, 2020
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01406717
Brief Title
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Official Title
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (undefined)
Primary Completion Date
November 4, 2015 (Actual)
Study Completion Date
November 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
SPIL1033, type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPIL1033
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPIL1033
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
Time Frame
24 weeks
Title
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
Time Frame
24 weeks
Title
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
Time Frame
24 weeks
Title
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
Time Frame
24 weeks
Title
Change From Baseline in Triglycerides
Time Frame
24 weeks
Title
Change From Baseline in Low Density Lipoproteins
Time Frame
24 weeks
Title
Change From Baseline in High Density Lipoproteins
Time Frame
24 weeks
Title
Change in Body Weight
Time Frame
24 weeks
Title
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
Time Frame
24 weeks
Title
Change From Baseline in Very Low Density Lipoproteins
Time Frame
24 weeks
Title
Change From Baseline in Total Cholesterol
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
SPIL Site 22
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
SPIL Site 25
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
SPIL Site 26
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
SPIL Site 23
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
Facility Name
SPIL Site 1
City
Ahmedabad
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 2
City
Ahmedabad
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 3
City
Ahmedabad
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 5
City
Rajkot
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 6
City
Surat
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 7
City
Surat
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 8
City
Surat
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 9
City
Surat
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 10
City
Vadodara
State/Province
Gujrat
Country
India
Facility Name
SPIL Site 19
City
Bangalore
State/Province
kARNATAKA
Country
India
Facility Name
SPIL Site 30
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
SPIL Site 31
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
SPIL Site 33
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
SPIL Site 29
City
Manipal
State/Province
Karnataka
Country
India
Facility Name
SPIL Site 35
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
SPIL Site 21
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
SPIL Site 24
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
SPIL Site 32
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
SPIL Site 11
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
SPIL Site 12
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
SPIL Site 13
City
Bhubaneshwar
State/Province
Orrissa
Country
India
Facility Name
SPIL Site 14
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
SPIL Site 15
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
SPIL Site 34
City
Vellore
State/Province
Tamil Nadu
Country
India
Facility Name
SPIL Site 16
City
Chennai
State/Province
Tamilnadu
Country
India
Facility Name
SPIL Site 17
City
Coimbatore
State/Province
Tamilnadu
Country
India
Facility Name
SPIL Site 20
City
Coimbatore
State/Province
Tamilnadu
Country
India
Facility Name
SPIL Site 18
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625020
Country
India
Facility Name
SPIL Site 27
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
SPIL Site 28
City
Lucknow
State/Province
Uttar Pradesh
Country
India

12. IPD Sharing Statement

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

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