A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
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
2 other identifiers
interventional
203
1 country
6
Brief Summary
This study is a multicentre, randomized, open label on comparison of pancreatic beta cell recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population and General safety in terms of occurrence of adverse events
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Dec 2013
Longer than P75 for phase_4 type-2-diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 27, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 2, 2019
April 1, 2019
3.9 years
July 27, 2016
April 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Insulin secretion rate
To compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic subjects as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L)
Baseline and 96 weeks
Secondary Outcomes (10)
Changes in HbA1c reduction
Baseline and 96 weeks
Changes in C peptide response
Baseline and 96 weeks
Changes in Insulin to glucose ratio
Baseline and 96 weeks
Changes in Fasting plasma glucose
Baseline and 96 weeks
Changes in 2hr postprandial plasma glucose
Baseline and 96 weeks
- +5 more secondary outcomes
Study Arms (2)
Metformin
ACTIVE COMPARATORTablet Metformin 1000 - 2500 mg/day for 96 weeks
Vildagliptin
EXPERIMENTALTablet Vildagliptin 100mg/day for 96 weeks
Interventions
Participant will be instructed to take Metformin tablets as per instructions given by the physician.
Participant will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner
Eligibility Criteria
You may qualify if:
- 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
- Male and female subjects of age between 20 - 60 years shall be selected
- Adult subjects willing to give informed consent
- Subject must be available for and willing to attend all evaluation visits
- Willingness to follow the protocol requirements as evidenced by written informed consent
- Subject must have access to telephone for calling into the clinical center as part of test product compliance
You may not qualify if:
- 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 ULN)
- Gamma-glutamyltransferase \>2 times upper limit of normal (ULN) at Visit1, confirmed by repeated measure within 3 working days
- Urine albumin: creatinine ratio (UACR) \>1800 mg/g (\>203.4 mg/mmol)
- Subjects 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
- Subject who is not willing to participate in the study
- Clinically significant abnormal laboratory results at screening.
- Subject is being treated for severe active infection of any type
- A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Jnana Sanjeevini Medical Centre
Bangalore, Karnataka, 560 078, India
Vikas Pai Research Foundation
Pune, Maharashtra, 411 005, India
Singhvi Health Centre
Chennai, Tamil Nadu, 600 019, India
Dr V.Seshiah Diabetes research Institute, Dr V.Balaji Diabetes care centre
Chennai, Tamil Nadu, 600029, India
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625 020, India
Ramana Maharishi Rangammal Hospital
Tiruvannamalai, Tamil Nadu, 606 603, India
Related Publications (1)
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PMID: 32501595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ambady Ramachandran, MD,Ph.D,D.Sc
President, India Diabetes Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2016
First Posted
August 3, 2016
Study Start
December 1, 2013
Primary Completion
November 1, 2017
Study Completion
December 1, 2018
Last Updated
April 2, 2019
Record last verified: 2019-04