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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2014/01/004301 | Other Identifier | Clinical Trail Registry - India |
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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
The subjects will be invited to the study center from the local population who are willing to participate in the trial. Each subject will be informed both orally and in writing about the study prior to inclusion in the study and only the subjects who give written informed consent will be included. The selection of the subjects is based on the inclusion and exclusion criteria defined in the protocol. The selected subjects will be given a screening number and subjected to screening procedure to find out eligible candidates for enrollment. The screening procedure includes obtaining subject's anthropometric data, baseline symptomatology, medical history, physical examination, laboratory investigations like blood glucose (fasting, 30min & 2hr after meal), HbA1c, ^Plasma insulin (fasting, 30min & 2hr after meal), ^2hr C peptide, Serum Amylase, Lipase, Urea, Creatinine, Gamma-glutamyl transferase (GGT), Urine albumin/creatinine ratio and urine pregnancy (if applicable).
The selected subjects after the screening procedure will be given a subject number and randomized between two arms. In Arm 1 they will be advised to take Vildagliptin 100mg daily for 96 weeks. In Arm 2 they are assigned Metformin (1000mg - 2500 mg/ day according to physician's preference for 96 weeks and all the subjects will be asked to come for follow up on week 12, week 24, week 48, week 72 and week 96. Subjects will be given sufficient quantity of study drugs. They 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 or Metformin tablets as per instructions given by the physician. Subjects will be instructed to maintain the record of dosing details in the patient diary.
Blood samples will be taken for the investigations such as blood glucose (fasting, 30min & 2hr after meal), HbA1c, Plasma insulin (fasting, 30min & 2hr after meal), C peptide (2hr after meal), fasting serum Amylase, Lipase, Urea, Creatinine, GGT, Urine albumin/creatinine ratio and Urine pregnancy test(if required) as specified in visit chart below. There will be three telephonic visits on week 36, week 60 and week 84. During those visits subject will be inquired about the health status over the phone and the drugs for the next three months will be dispensed by courier or delivered at home by the coordinator.
If the glycaemic control is constantly not satisfactory (HbA1c ≥ 8.5%) from visit 3, a rescue drug (Glimepiride) will be added to both arms and all the clinical and biochemical test will be done as per visit chart. With Glimepiride if the A1C is >9% insulin will be added and the subject will be withdrawn from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Tablet Metformin 1000 - 2500 mg/day for 96 weeks |
|
| Vildagliptin | Experimental | Tablet Vildagliptin 100mg/day for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participant will be instructed to take Metformin tablets as per instructions given by the physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ambady Ramachandran, MD,Ph.D,D.Sc | President, India Diabetes Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jnana Sanjeevini Medical Centre | Bangalore | Karnataka | 560 078 | India | ||
| Vikas Pai Research Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32501595 | Derived | 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. |
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| Vildagliptin | Drug | 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 |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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