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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406717
• Other study ID #: CLR_10_33
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2013
• Est. completion date: November 4, 2015

Study information

• Verified date: July 2020
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: November 4, 2015
• Est. primary completion date: November 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	SPIL Site 1	Ahmedabad	Gujrat
India	SPIL Site 2	Ahmedabad	Gujrat
India	SPIL Site 3	Ahmedabad	Gujrat
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 13	Bhubaneshwar	Orrissa
India	SPIL Site 16	Chennai	Tamilnadu
India	SPIL Site 17	Coimbatore	Tamilnadu
India	SPIL Site 20	Coimbatore	Tamilnadu
India	SPIL Site 22	Hyderabad	Andhra Pradesh
India	SPIL Site 25	Hyderabad	Andhra Pradesh
India	SPIL Site 26	Hyderabad	Andhra Pradesh
India	SPIL Site 35	Indore	Madhya Pradesh
India	SPIL Site 14	Jaipur	Rajasthan
India	SPIL Site 15	Jaipur	Rajasthan
India	SPIL Site 27	Lucknow	Uttar Pradesh
India	SPIL Site 28	Lucknow	Uttar Pradesh
India	SPIL Site 18	Madurai	Tamilnadu
India	SPIL Site 29	Manipal	Karnataka
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 5	Rajkot	Gujrat
India	SPIL Site 6	Surat	Gujrat
India	SPIL Site 7	Surat	Gujrat
India	SPIL Site 8	Surat	Gujrat
India	SPIL Site 9	Surat	Gujrat
India	SPIL Site 10	Vadodara	Gujrat
India	SPIL Site 34	Vellore	Tamil Nadu
India	SPIL Site 23	Visakhapatnam	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)		24 weeks
Primary	Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)		24 weeks
Primary	Count and Percentage of Subjects Positive for Anti-exenatide Antibodies		24 weeks
Primary	Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)		24 weeks
Secondary	Change From Baseline in 2hour Postprandial Glucose (2-h PPG)		24 weeks
Secondary	Change From Baseline in Triglycerides		24 weeks
Secondary	Change From Baseline in Low Density Lipoproteins		24 weeks
Secondary	Change From Baseline in High Density Lipoproteins		24 weeks
Secondary	Change in Body Weight		24 weeks
Secondary	Subjects Achieving Hemoglobin A1c (HbA1c) < 7%		24 weeks
Secondary	Change From Baseline in Very Low Density Lipoproteins		24 weeks
Secondary	Change From Baseline in Total Cholesterol		24 weeks