Health Condition 1: null- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: P2202: In Stage I, P2202 will be administered at 1000 mg once in aday for a period of 12 weeks.
After the Stage I analysis, dose levels for Stage II will be selected based on the PK-PD
Sponsors
Piramal Life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adult male and females between 18 years to 65 years of age with a BMI more than or equal to 27 kg/m2 but less than or equal to 40 kg/m2, inclusively. Subjects with established type 2 diabetes mellitus Subjects with HbA1c level more than or equal to 7.5% and less than 10% at screening. Subjects who are on a stable dose of Metformin and/or Sulfonylurea Subjects with fasting plasma glucose of less than or equal to 14.4 mmol/L and at least 5.5 mmol/L prior to randomization Subjects with a C-peptide value of > 0.299 nmol/L (0.9 ng/mL) at the screening visit Subjects with serum LDL-C more than or equal to 3.10 mmol/L and less than or equal to 4.89 mmol/L Subjects with serum triglycerides more than or equal to1.69 mmol/L and less than or equal to 6.76 mmol/L. Non-surgically sterile male subjects with partner(s) of childbearing potential who must be must be willing to use contraception throughout the study and ensure that their partner(s) will use simultaneously effective means of contraception during this period. Non-childbearing potential female subjects who have sexual intercourse with a non-sterile male partner will be advised to use an acceptable method of contraception throughout the study Negative pregnancy test at screening
Exclusion criteria
Exclusion criteria: Subjects with type 1 diabetes mellitus, maturity-onset diabetes of the young or any rare form of diabetes. Subjects with hyperglycemia due to secondary causes or frequent hypoglycemic events Subjects with a history of acute diabetic complications prior to screening Subjects treated with insulin or other anti-diabetic agents prior to screening Subjects who received systemic glucocorticoids prior to screening Subjects with a history of clinically significant disease other than type 2 diabetes, which in the investigator?s opinion will disallow him/her from completing the current study Subjects with a history of uncontrolled hypertension or secondary hypertension Subjects with abnormal renal and hepatic function Subjects who have received any investigational new drug prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1cTimepoint: baseline and end of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting plasma glucose, fasting serum insulin and fasting serum C-peptideTimepoint: baseline and end of study visit.;fasting serum lipidsTimepoint: baseline and end of study;serum adiponectin and serum leptinTimepoint: baseline and end of study visit.;serum hsCRPTimepoint: baseline and end of study | — |
Countries
Canada, India
Contacts
Public ContactDr Purvi Chawla
Piramal Life sciences Ltd Mumbai
Outcome results
None listed