Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT01406717
Last Updated: 2020-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
360 participants
INTERVENTIONAL
2013-03-01
2015-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SPIL1033
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.
Placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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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, India
SPIL Site 34
Vellore, Tamil Nadu, India
SPIL Site 27
Lucknow, Uttar Pradesh, India
SPIL Site 28
Lucknow, Uttar Pradesh, India
Countries
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Other Identifiers
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CLR_10_33
Identifier Type: -
Identifier Source: org_study_id
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