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

This study has been terminated.
(The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: July 25, 2013
Last updated: September 22, 2015
Last verified: September 2015
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) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: July 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Vildagliptin plus metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
Drug: Vildagliptin
Vildagliptin 50 mg twice daily
Drug: Metformin
Metformin (1000-1500 mg daily)
Active Comparator: Group B: Glimepiride plus metformin
Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).
Drug: Glimepiride
Glimepiride 1-6 mg once daily
Drug: Metformin
Metformin (1000-1500 mg daily)


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

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
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Please refer to this study by its identifier: NCT01910441

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01910441     History of Changes
Other Study ID Numbers: CLAF237AIN03 
Study First Received: July 25, 2013
Results First Received: September 22, 2015
Last Updated: September 22, 2015
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
Anti-Arrhythmia Agents
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 25, 2016