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Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Vildagliptin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, type 2, vildagliptin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Outpatients who were 20 years of age and older with diagnosis of T2DM.
Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
Understood the nature of the study, and had signed informed consent form.

Exclusion criteria

Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
Female patients who needed to lactate during the study.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vildagliptin plus metformin (SPC)

Arm Description

Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Secondary Outcome Measures

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24

FPG analysis will be performed on a blood sample obtained by study personnel.

Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24

PPG analysis will be performed on a blood sample obtained by study personnel.

Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week

Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.

The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment

Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.

Full Information

NCT ID

NCT01582243

First Posted

April 18, 2012

Last Updated

September 15, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01582243

Brief Title

Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

Official Title

A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment

6. Conditions and Keywords

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

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, type 2, vildagliptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin plus metformin (SPC)

Arm Type

Experimental

Arm Description

Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Other Intervention Name(s)

LAF237, Galvus Met

Intervention Description

Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Description

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

Description

HbA1c analysis will be performed on a blood sample obtained by study personnel.

Time Frame

Baseline, week 12

Title

Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24

Description

FPG analysis will be performed on a blood sample obtained by study personnel.

Time Frame

Baseline, week 12, week 24

Title

Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24

Description

PPG analysis will be performed on a blood sample obtained by study personnel.

Time Frame

Baseline, week, week 24

Title

Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week

Description

Time Frame

Baseline, week 24

Title

The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment

Description

Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.

Time Frame

week 12, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Outpatients who were 20 years of age and older with diagnosis of T2DM. Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%. Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study. Understood the nature of the study, and had signed informed consent form. Exclusion criteria Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin. Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1. Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1. Female patients who needed to lactate during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

12. IPD Sharing Statement

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Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

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