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A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853630
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

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

Condition or disease Intervention/treatment Phase
TYpe 2 Diabetes Mellitus Drug: Metformin Drug: Vildagliptin Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Metformin
Tablet Metformin 1000 - 2500 mg/day for 96 weeks
Drug: Metformin
Participant will be instructed to take Metformin tablets as per instructions given by the physician.

Experimental: Vildagliptin
Tablet Vildagliptin 100mg/day for 96 weeks
Drug: Vildagliptin
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




Primary Outcome Measures :
  1. Changes in Insulin secretion rate [ Time Frame: Baseline and 96 weeks ]
    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)


Secondary Outcome Measures :
  1. Changes in HbA1c reduction [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction

  2. Changes in C peptide response [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of C peptide response

  3. Changes in Insulin to glucose ratio [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of insulin to glucose ratio

  4. Changes in Fasting plasma glucose [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in fasting plasma glucose

  5. Changes in 2hr postprandial plasma glucose [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in 2hr postprandial plasma glucose

  6. Changes in Insulin sensitivity [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in insulin sensitivity

  7. Changes in Oral disposition index [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in oral disposition index

  8. Percentage of subjects reaching HbA1c ≤ 6.5% [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 6.5%

  9. Percentage of subjects reaching HbA1c ≤ 7.0% [ Time Frame: Baseline and 96 weeks ]
    Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 7.0%

  10. Number of participant treated related to adverse event [ Time Frame: Baseline and 96 weeks ]
    Number of adverse event observed in both Vildagliptin and Metformin treatment group will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

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 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
  • Subject with clinically relevant uncontrolled medical condition (e.g hematologic renal hepatic neurology cardiac or respiratory)
  • Subject 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 subjects ability to complete the study or its measures or that may pose significant risk to the subject

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853630


Locations
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India
Jnana Sanjeevini Medical Centre
Bangalore, Karnataka, India, 560 078
Vikas Pai Research Foundation
Pune, Maharashtra, India, 411 005
Singhvi Health Centre
Chennai, Tamil Nadu, India, 600 019
Dr V.Seshiah Diabetes research Institute, Dr V.Balaji Diabetes care centre
Chennai, Tamil Nadu, India, 600029
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, India, 625 020
Ramana Maharishi Rangammal Hospital
Tiruvannamalai, Tamil Nadu, India, 606 603
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Investigators
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Principal Investigator: Ambady Ramachandran, MD,Ph.D,D.Sc President, India Diabetes Research Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier: NCT02853630    
Other Study ID Numbers: CLAF237AIN04
CTRI/2014/01/004301 ( Other Identifier: Clinical Trail Registry - India )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Vildagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action