| Trial ID: | L1832 |
| Source ID: | NCT02853630
|
| Associated Drug: |
Metformin
|
| Title: |
A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
TYpe 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin|DRUG: Vildagliptin
|
| Outcome Measures: |
Primary: 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: Changes in HbA1c reduction, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction, Baseline and 96 weeks|Changes in C peptide response, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of C peptide response, Baseline and 96 weeks|Changes in Insulin to glucose ratio, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of insulin to glucose ratio, Baseline and 96 weeks|Changes in Fasting plasma glucose, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in fasting plasma glucose, Baseline and 96 weeks|Changes in 2hr postprandial plasma glucose, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in 2hr postprandial plasma glucose, Baseline and 96 weeks|Changes in Insulin sensitivity, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in insulin sensitivity, Baseline and 96 weeks|Changes in Oral disposition index, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in oral disposition index, Baseline and 96 weeks|Percentage of subjects reaching HbA1c ≤ 6.5%, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 6.5%, Baseline and 96 weeks|Percentage of subjects reaching HbA1c ≤ 7.0%, Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 7.0%, Baseline and 96 weeks|Number of participant treated related to adverse event, Number of adverse event observed in both Vildagliptin and Metformin treatment group will be assessed, Baseline and 96 weeks
|
| Sponsor/Collaborators: |
Sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
203
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12
|
| Completion Date: |
2018-12
|
| Results First Posted: |
|
| Last Update Posted: |
2019-04-02
|
| Locations: |
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
|
| URL: |
https://clinicaltrials.gov/show/NCT02853630
|
