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

September 22, 2015 updated by: Novartis Pharmaceuticals

A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Metformin
Metformin (1000-1500 mg daily)
Drug: Glimepiride
Glimepiride 1-6 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Amplitude of Glycemic Excursions (MAGE)
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237AIN03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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