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

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ClinicalTrials.gov Identifier: NCT01910441
Recruitment Status : Terminated (The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.)
First Posted : July 29, 2013
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Mean Amplitude of Glycemic Excursions (MAGE) [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01910441


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01910441     History of Changes
Other Study ID Numbers: CLAF237AIN03
First Posted: July 29, 2013    Key Record Dates
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015
Last Verified: September 2015

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

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