Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
360
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Mar 2013
Longer than P75 for phase_3 type-2-diabetes-mellitus
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2015
CompletedResults Posted
Study results publicly available
November 1, 2019
CompletedAugust 11, 2020
July 1, 2020
2.7 years
July 28, 2011
October 5, 2019
July 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
SPIL1033
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
SPIL Site 22
Hyderabad, Andhra Pradesh, India
SPIL Site 25
Hyderabad, Andhra Pradesh, India
SPIL Site 26
Hyderabad, Andhra Pradesh, India
SPIL Site 23
Visakhapatnam, Andhra Pradesh, India
SPIL Site 1
Ahmedabad, Gujarat, India
SPIL Site 2
Ahmedabad, Gujarat, India
SPIL Site 3
Ahmedabad, Gujarat, India
SPIL Site 5
Rajkot, Gujarat, India
SPIL Site 6
Surat, Gujarat, India
SPIL Site 7
Surat, Gujarat, India
SPIL Site 8
Surat, Gujarat, India
SPIL Site 9
Surat, Gujarat, India
SPIL Site 10
Vadodara, Gujarat, India
SPIL Site 19
Bangalore, Karnataka, India
SPIL Site 30
Bangalore, Karnataka, India
SPIL Site 31
Bangalore, Karnataka, India
SPIL Site 33
Bangalore, Karnataka, India
SPIL Site 29
Manipal, Karnataka, India
SPIL Site 35
Indore, Madhya Pradesh, India
SPIL Site 21
Nagpur, Maharashtra, India
SPIL Site 24
Nagpur, Maharashtra, India
SPIL Site 32
Nashik, Maharashtra, India
SPIL Site 11
Pune, Maharashtra, India
SPIL Site 12
Pune, Maharashtra, India
SPIL Site 13
Bhubaneshwar, Orrissa, India
SPIL Site 14
Jaipur, Rajasthan, India
SPIL Site 15
Jaipur, Rajasthan, India
SPIL Site 16
Chennai, Tamil Nadu, India
SPIL Site 17
Coimbatore, Tamil Nadu, India
SPIL Site 20
Coimbatore, Tamil Nadu, India
SPIL Site 18
Madurai, Tamil Nadu, 625020, India
SPIL Site 34
Vellore, Tamil Nadu, India
SPIL Site 27
Lucknow, Uttar Pradesh, India
SPIL Site 28
Lucknow, Uttar Pradesh, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials
- Organization
- SPIL
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
March 1, 2013
Primary Completion
November 4, 2015
Study Completion
November 4, 2015
Last Updated
August 11, 2020
Results First Posted
November 1, 2019
Record last verified: 2020-07