NCT02853630.

Study name	—
Methods	Type of trial: efficacy trial Allocation: randomised Intervention model: parallel assignment Masking: none (open‐label) Primary purpose: treatment
Participants	Condition: T2DM Enrollment: 203 participants Inclusion criteria: newly diagnosed type 2 diabetes mellitus patients not receiving any medication for diabetes, HbA1c ranging from 7.0% to ≤ 8.5%, Body Mass Index (BMI) ≥ 19.0 to ≤ 25.0 kg/m2, males and females of age between 20 to 60 years shall be selected, adult participants willing to give informed consent,participant must be available for and willing to attend all evaluation visits, willingness to follow the protocol requirements as evidenced by written informed consent, participant must have access to telephone for calling into the clinical centre as part of test product compliance Exclusion criteria: type 1 diabetes, BMI ≤ 18.99 kg/m2 or > 25 kg/m2, presence of severe vascular complications, indications for use of insulin, elevated serum levels of lipase and amylase (> 1.5 upper limit of normal (ULN)), gamma‐glutamyltransferase > 2 times ULN at Visit 1, confirmed by repeated measure within 3 working days, urine albumin: creatinine ratio (UACR) > 1800 mg/g (> 203.4 mg/mmol), participants below the age of 20 years and above the age of 60 years, history of any drug abuse in the past 12 months, history of hypersensitivity to study drugs and related drugs or excipients in the formulation, history of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions, participant who is not willing to participate in the study, clinically significant abnormal laboratory results at screening, participant is being treated for severe active infection of any type, a female participant who is breast‐feeding, pregnant, or intends to become pregnant during the study, participant with clinically relevant uncontrolled medical condition (e.g. haematological, renal, hepatic, neurology, cardiac or respiratory), participant has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years, participating in a clinical research trial within 30 days prior to screening, donated blood 3 months prior to first study visit and during the study period, individuals who are cognitively impaired and or who are unable to give informed consent, known HIV or Hepatitis B‐ or C‐positive, any other health or mental condition that in the Investigator's opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant
Interventions	Intervention(s): metformin (1000 mg/day to 2500 mg/day) Comparator(s): vildagliptin (100 mg/day)
Outcomes	Primary outcome(s): changes in Insulin secretion rate Secondary outcome(s): changes in HbA1c reduction, changes in C peptide response, changes in Insulin to glucose ratio, changes in Fasting plasma glucose, changes in 2‐hour postprandial plasma glucose, changes in Insulin sensitivity, changes in Oral disposition index, percentage of participants reaching HbA1c ≤ 6.5%, percentage of participants reaching HbA1c ≤ 7.0%, number of participants treated related to adverse event Other outcome(s): —
Starting date	Trial start date: December 2013 Trial completion date: December 2018
Contact information	Responsible party/principal investigator: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Study identifier	Trial identifier: NCT02853630; CTRI/2014/01/004301
Official title	A multicentric, randomized, open label study on comparison of pancreatic beta cell recovery and preservation in Type 2 Diabetic patients treated with DPP‐4 inhibitor (Vildagliptin) and metformin
Stated purpose of study	—
Notes