A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
Condition: TYpe 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Metformin; Vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment