Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients (VARIABLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01910441
First received: July 25, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Vildagliptin
Drug: Glimepiride
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean amplitude of glycemic excursions (MAGE) using continuous glucose monitoring system (CGMS) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    MAGE has been shown to be independent of mean glycaemia and the greater the MAGE, the higher the glycaemic fluctuations. MAGE will be calculated from the arithmetic mean of the differences between consecutive peaks and nadirs; measurement in the peak-to-nadir or nadir-to-peak direction is determined by the first qualifying excursion (defined as exceeding the value of one standard deviation of the blood glucose for the same 24-hour period).


Secondary Outcome Measures:
  • Percent glycosylated hemoglobin reduction from baseline at 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Time to glycemic control assessed through CGMS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Glycemic control is defined as hypoglycemic range/hyperglycemic range and ideal glycemic range"

  • Percentage of patients reaching the glycemic targets after 16 weeks treatment, in the overall study population [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Patients reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii) HbA1c ≤ 7.0%

  • Number of unrecognized hypoglycemia events recognized by CGMS [ Time Frame: 6 days ] [ Designated as safety issue: No ]
  • Number of patients with adverse events, serious adverse events and death [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 324
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Vildagliptin plus metformin
Will receive Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily)
Drug: Vildagliptin
Vildagliptin 50 mg twice daily
Other Name: Group A
Drug: Metformin
Metformin (1000-1500 mg daily)
Active Comparator: Group B: Glimepiride plus metformin
Will receive Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily)
Drug: Glimepiride
Glimepiride 1-6 mg once daily
Other Name: Group B
Drug: Metformin
Metformin (1000-1500 mg daily)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have given written informed consent to participate in the study.
  2. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
  3. Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
  4. Patients with HbA1C levels within the range > 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

Exclusion Criteria:

  1. Age > 75 years ; BMI <22 or >40 kg/m2
  2. Patients who are on Insulin therapy at the time of study entry.
  3. Type 1 Diabetes Mellitus patients.
  4. Patients with severe renal (creatinine clearance < 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST > 3 x ULN).

    Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)

  5. Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.

Other protocol defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910441

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
India
Novartis Investigative Site Recruiting
Hyderabad, Andhra Pradesh, India, 500 096
Novartis Investigative Site Not yet recruiting
New Delhi, Delhi, India, 110076
Novartis Investigative Site Not yet recruiting
Bangalore, Karnataka, India, 560 008
Novartis Investigative Site Not yet recruiting
Bangalore, Karnataka, India, 560034
Novartis Investigative Site Not yet recruiting
Mumbai, Maharashtra, India
Novartis Investigative Site Not yet recruiting
Mumbai, Maharashtra, India, 400 058
Novartis Investigative Site Not yet recruiting
Pune, Maharashtra, India, 411004
Novartis Investigative Site Recruiting
Pune, Maharashtra, India, 411 040
Novartis Investigative Site Not yet recruiting
Madurai, Tamil Nadu, India, 625 020
Novartis Investigative Site Recruiting
Lucknow, Uttar Pradesh, India, 226003
Novartis Investigative Site Not yet recruiting
Lucknow, Uttar Pradesh, India, 226014
Novartis Investigative Site Not yet recruiting
Varanasi, Uttar Pradesh, India, 221 005
Novartis Investigative Site Not yet recruiting
Kolkatta, West Bengal, India, 700 027
Novartis Investigative Site Not yet recruiting
Bangalore, India, 560043
Novartis Investigative Site Recruiting
Bhubaneswar, India, 751005
Novartis Investigative Site Recruiting
Coimbatore, India, 641009
Novartis Investigative Site Recruiting
Coimbatore, India, 641018
Novartis Investigative Site Recruiting
Kolkata, India, 700054
Novartis Investigative Site Not yet recruiting
New Delhi, India, 110 017
Novartis Investigative Site Recruiting
New Delhi, India, 110017
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01910441     History of Changes
Other Study ID Numbers: CLAF237AIN03
Study First Received: July 25, 2013
Last Updated: July 7, 2014
Health Authority: India: Drugs Controller General of India (DCGI)

Keywords provided by Novartis:
Type 2 Diabetes Mellitus, Glycemic variability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Metformin
Vildagliptin
Anti-Arrhythmia Agents
Cardiovascular Agents
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014