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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Vildagliptin

Glimepiride

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Glycemic variability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have given written informed consent to participate in the study.
Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%).
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:

Age > 75 years ; BMI <22 or >40 kg/m2
Patients who are on Insulin therapy at the time of study entry.
Type 1 Diabetes Mellitus patients.
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)
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Vildagliptin plus metformin

Group B: Glimepiride plus metformin

Arm Description

Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).

Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Outcomes

Primary Outcome Measures

Mean Amplitude of Glycemic Excursions (MAGE)

Secondary Outcome Measures

Full Information

NCT ID

NCT01910441

First Posted

July 25, 2013

Last Updated

September 22, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01910441

Brief Title

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

Acronym

VARIABLE

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 Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated due to the unavailability of Continuous Glucose Monitoring sensors (CGMS) which were required to assess the primary end-point.

Study Start Date

July 2013 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Glycemic variability

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: Vildagliptin plus metformin

Arm Type

Experimental

Arm Description

Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).

Arm Title

Group B: Glimepiride plus metformin

Arm Type

Active Comparator

Arm Description

Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Intervention Description

Vildagliptin 50 mg twice daily

Intervention Type

Drug

Intervention Name(s)

Glimepiride

Intervention Description

Glimepiride 1-6 mg once daily

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Metformin (1000-1500 mg daily)

Primary Outcome Measure Information:

Title

Mean Amplitude of Glycemic Excursions (MAGE)

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have given written informed consent to participate in the study. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive). Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c > 7.5 - 9%). 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: Age > 75 years ; BMI <22 or >40 kg/m2 Patients who are on Insulin therapy at the time of study entry. Type 1 Diabetes Mellitus patients. 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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