Clinical trial NCT01406717: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: SPIL1033
type 2 diabetes mellitus
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
timeFrame: 24 weeks
measure: Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
timeFrame: 24 weeks
measure: Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
timeFrame: 24 weeks
measure: Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
timeFrame: 24 weeks
measure: Change From Baseline in Triglycerides
timeFrame: 24 weeks
measure: Change From Baseline in Low Density Lipoproteins
timeFrame: 24 weeks
measure: Change From Baseline in High Density Lipoproteins
timeFrame: 24 weeks
measure: Change in Body Weight
timeFrame: 24 weeks
measure: Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
timeFrame: 24 weeks
measure: Change From Baseline in Very Low Density Lipoproteins
timeFrame: 24 weeks
measure: Change From Baseline in Total Cholesterol
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SPIL Site 22
state: Andhra Pradesh
city: Hyderabad
country: India
facility: SPIL Site 25
state: Andhra Pradesh
city: Hyderabad
country: India
facility: SPIL Site 26
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: SPIL Site 23
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: SPIL Site 1
state: Gujrat
city: Ahmedabad
country: India
facility: SPIL Site 2
state: Gujrat
city: Ahmedabad
country: India
facility: SPIL Site 3
state: Gujrat
city: Rajkot
country: India
facility: SPIL Site 5
state: Gujrat
city: Surat
country: India
facility: SPIL Site 6
state: Gujrat
city: Surat
country: India
facility: SPIL Site 7
state: Gujrat
city: Surat
country: India
facility: SPIL Site 8
state: Gujrat
city: Surat
country: India
facility: SPIL Site 9
state: Gujrat
city: Vadodara
country: India
facility: SPIL Site 10
state: Gujrat
city: Bangalore
country: India
facility: SPIL Site 19
state: kARNATAKA
city: Bangalore
country: India
facility: SPIL Site 30
state: Karnataka
city: Bangalore
country: India
facility: SPIL Site 31
state: Karnataka
city: Bangalore
country: India
facility: SPIL Site 33
state: Karnataka
city: Manipal
country: India
facility: SPIL Site 29
state: Karnataka
city: Indore
country: India
facility: SPIL Site 35
state: Madhya Pradesh
city: Nagpur
country: India
facility: SPIL Site 21
state: Maharashtra
city: Nagpur
country: India
facility: SPIL Site 24
state: Maharashtra
city: Nashik
country: India
facility: SPIL Site 32
state: Maharashtra
city: Pune
country: India
facility: SPIL Site 11
state: Maharashtra
city: Pune
country: India
facility: SPIL Site 12
state: Maharashtra
city: Bhubaneshwar
country: India
facility: SPIL Site 13
state: Orrissa
city: Jaipur
country: India
facility: SPIL Site 14
state: Rajasthan
city: Jaipur
country: India
facility: SPIL Site 15
state: Rajasthan
city: Vellore
country: India
facility: SPIL Site 34
state: Tamil Nadu
city: Chennai
country: India
facility: SPIL Site 16
state: Tamilnadu
city: Coimbatore
country: India
facility: SPIL Site 17
state: Tamilnadu
city: Coimbatore
country: India
facility: SPIL Site 20
state: Tamilnadu
city: Madurai
country: India
facility: SPIL Site 18
state: Tamilnadu
city: Lucknow
country: India
facility: SPIL Site 27
state: Uttar Pradesh
city: Lucknow
country: India
facility: SPIL Site 28
state: Uttar Pradesh
Study officials:
References: