Health Condition 1: null- Type 2 diabetes mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Exenatide injection:
: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the next 20 weeks. To be self-administered twice daily in the thigh, abdomen, or upper arm wit
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjects 20 years of age and older. 2.Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy. 3.Weight stable 4.Women of child-bearing potential must be practicing an acceptable method of birth control as judged by the investigator 5.Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Previous exposure to exenatide 2.Current or previous exposure to insulin. 3.Used drugs for weight loss 4.Currently treated with any of the excluded medications 5.Received treatment within the last 3 months with a drug that has not received regulatory approval for indication at the time of trial entry 6.Type 1 diabetes mellitus. 7.Severe renal impairment 8.A history of renal transplantation or currently on renal dialysis. 9.History of pancreatitis. 10.A known allergy to any components contained in the exenatide injection. 11.A history of severe gastrointestinal disease 12.Pregnant or lactating females 13.History of chronic pancreatitis 14.Immunosuppressed or requiring treatment with an immunosuppressant or recently received an immunosuppressant, including systemic corticosteroids. 15.History of immune deficiency syndrome or HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end-of-study in:HbA1c and FPG Timepoint: End-of-study Visit 8, Week 24 (Day 169+/-2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline to end-of-study in: 2-h PPG, Fasting Lipid profile (Total cholesterol, LDL, HDL, VLDL and Triglycerides) and- Body weight Timepoint: baseline and end-of-study | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd
Outcome results
None listed