Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Vildagliptin: 50mg BD for 96 weeks
Control Intervention1: Metformin: 1000â??2500mg for 96 weeks
Sponsors
India Diabetes Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly Diagnosed Type 2 Diabetes Mellitus patients not receiving any medication for diabetes 2.HbA1c ranging from 7.0% to 3.BMI >= 19.0 to 4.Male and female subjects of age between 20 - 60 years shall be selected 5.Women of child-bearing potential must use effective methods of contraception during dosing of study treatment 6.Adult subjects willing to give informed consent 7.Subject must be available for and willing to attend all evaluation visits 8.Willingness to follow the protocol requirements as evidenced by written informed consent 9.Subject must have access to telephone for calling into the clinical center as part of test product compliance
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes 2.BMI 25 kg/m2 3.Presence of severe vascular complications 4.Indications for use of insulin 5.Elevated serum levels of lipase and amylase ( >1.5 ULN) 6.Gamma-glutamyltransferase >2 times upper limit of normal (ULN) at Visit1, confirmed by repeated measure within 3 working days 7.Urine albumin: creatinine ratio (UACR) >1800 mg/g ( >203.4 mg/mmol) 8.Subjects below the age of 20 years and above the age of 60 years 9.History of any drug abuse in the past 12 months 10.History of hypersensitivity to study drugs and related drugs or excipients in the formulation. 11.History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions 12.Subject who is not willing to participate in the study 13.Clinically significant abnormal laboratory results at screening. 14.Subject is being treated for severe active infection of any type 15.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study 16.Subject with clinically relevant uncontrolled medical conditione eg hematologic renal hepatic neurologic cardiac or respiratory) 17.Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years 18.Participating in a clinical research trial within 30 days prior to screening 19.Donated blood 3 months prior to first study visit and during the study period 20.Individuals who are cognitively impaired and or who are unable to give informed consent 21.Known HIV or Hepatitis B or C positive 22.Any other health or mental condition that in the Investigator s opinion may adversely affect the subjects ability to complete the study or its measures or that may pose significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin secretion rateTimepoint: 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| C-peptide responsesTimepoint: 96 weeks;General safety of drugsTimepoint: 96 weeks;HbA1c â?¤ 6.5%Timepoint: 96 weeks;HbA1c â?¤ 7.0%Timepoint: 96 weeks;HbA1c reductionTimepoint: 96 weeks;Improvement in insulin sensitivityTimepoint: 96 weeks;Improvement in oral disposition indexTimepoint: 96 weeks;Insulin to glucose ratiosTimepoint: 96 weeks;Reduction in 2hr postprandial glucoseTimepoint: 96 weeks;Reduction in fasting plasma glucoseTimepoint: 96 weeks | — |
Countries
India
Contacts
Public ContactDrSatheesh
India Diabetes Research Foundation
Outcome results
None listed