Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Vildagliptin

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Vildagliptin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
C-peptide >0.6 ng/ml (>0.20 nmol/L).
HbA1c ≥7.5 to ≤11% at Visit 1
Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for participation in the study

Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
Pregnant or lactating women
Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
Current diagnosis of congestive heart failure (NYHA III or IV).
Myocardial infarction (MI) within the past 6 months
Liver disease such as cirrhosis or chronic active hepatitis

Other protocol defined inclusion/excusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population

HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population

HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

Secondary Outcome Measures

Number of patients with adverse events, serious adverse events and death on over all population

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population

FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

Percentage of patients meeting responder criteria after 24 weeks treatment on overall population

Responder rate will be analyzed in the following categories: Endpoint HbA1c ≤ 6.5% Endpoint HbA1c < 7% Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

Number of patients with adverse events, serious adverse events and death on Chinese population

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population

FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population

Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

Full Information

NCT ID

NCT01582230

First Posted

April 18, 2012

Last Updated

August 29, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01582230

Brief Title

Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Official Title

A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.

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, Vildagliptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

293 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vildagliptin

Arm Type

Experimental

Arm Description

Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Vildagliptin

Other Intervention Name(s)

Galvus, LAF237

Intervention Description

Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks

Primary Outcome Measure Information:

Title

Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population

Description

HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

Time Frame

Baseline and every study visit up to 24 weeks

Title

Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population

Description

HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.

Time Frame

Baseline and every study visit up to 24 weeks

Secondary Outcome Measure Information:

Title

Number of patients with adverse events, serious adverse events and death on over all population

Description

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time Frame

24 weeks

Title

Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population

Description

FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

Time Frame

Baseline, week 24

Title

Percentage of patients meeting responder criteria after 24 weeks treatment on overall population

Description

Responder rate will be analyzed in the following categories: Endpoint HbA1c ≤ 6.5% Endpoint HbA1c < 7% Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

Time Frame

After 24 weeks

Title

Number of patients with adverse events, serious adverse events and death on Chinese population

Description

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time Frame

24 weeks

Title

Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population

Description

FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.

Time Frame

Baseline, week 24

Title

Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population

Description

Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed

Time Frame

After 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria C-peptide >0.6 ng/ml (>0.20 nmol/L). HbA1c ≥7.5 to ≤11% at Visit 1 Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1 Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for participation in the study Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1 Pregnant or lactating women Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months Current diagnosis of congestive heart failure (NYHA III or IV). Myocardial infarction (MI) within the past 6 months Liver disease such as cirrhosis or chronic active hepatitis Other protocol defined inclusion/excusion criteria may apply

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

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Changsha City

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

Novartis Investigative Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410003

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210006

Country

China

Facility Name

Novartis Investigative Site

City

Wu Xi

State/Province

Jiangsu

ZIP/Postal Code

214023

Country

China

Facility Name

Novartis Investigative Site

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

Novartis Investigative Site

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110003

Country

China

Facility Name

Novartis Investigative Site

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250031

Country

China

Facility Name

Novartis Investigative Site

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610072

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

Novartis Investigative Site

City

Metro Manila

ZIP/Postal Code

1500

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasay City

ZIP/Postal Code

1300

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

768825

Country

Singapore

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

25929739

Citation

Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.

Results Reference

derived

Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial