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Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vildagliptin
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Add-on to insulin

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed diagnosis of T2DM
  • On a stable dose of insulin as defined by the protocol
  • On a stable does of metformin (if applicable) as defined by the protocol
  • Age 18 to 80 years
  • HbA1c of 7.5 to 11.0%
  • Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • Short-acting or rapid-acting insulin
  • Pregnancy or lactation
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site #3
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site #3
  • Novartis Investigative Site #4
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site #3
  • Novartis Investigative Site #4
  • Novartis Investigative Site #5
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #2
  • Novartis Investigative Site #1
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site #3
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site #1
  • Novartis Investigative Site #2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

HbA1c reduction

Secondary Outcome Measures

HbA1c reduction in subpopulation treated with insulin and with metformin
HbA1c reduction in subpopulation treated with insulin and without metformin
Reduction in FPG (overall and subpopulations)
Responder rates (overall and subpopulations)
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)

Full Information

First Posted
October 18, 2010
Last Updated
February 21, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01224366
Brief Title
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin 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
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Add-on to insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
HbA1c reduction
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
HbA1c reduction in subpopulation treated with insulin and with metformin
Time Frame
24 weeks
Title
HbA1c reduction in subpopulation treated with insulin and without metformin
Time Frame
24 weeks
Title
Reduction in FPG (overall and subpopulations)
Time Frame
24 weeks
Title
Responder rates (overall and subpopulations)
Time Frame
24 weeks
Title
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
Time Frame
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: Confirmed diagnosis of T2DM On a stable dose of insulin as defined by the protocol On a stable does of metformin (if applicable) as defined by the protocol Age 18 to 80 years HbA1c of 7.5 to 11.0% Body Mass Index (BMI) 22 to 40 kg/m2 Exclusion Criteria: Type 1 diabetes Short-acting or rapid-acting insulin Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol 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 Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Box Hill
Country
Australia
Facility Name
Novartis Investigative Site
City
Heidelberg Heights
Country
Australia
Facility Name
Novartis Investigative Site
City
Parkville
Country
Australia
Facility Name
Novartis Investigative Site #1
City
Wollongong
Country
Australia
Facility Name
Novartis Investigative Site #2
City
Wollongong
Country
Australia
Facility Name
Novartis Investigative Site
City
Bonheiden
Country
Belgium
Facility Name
Novartis Investigative Site
City
Edegem
Country
Belgium
Facility Name
Novartis Investigative Site
City
Genk
Country
Belgium
Facility Name
Novartis Investigative Site
City
La Louviere
Country
Belgium
Facility Name
Novartis Investigative Site
City
Ronse
Country
Belgium
Facility Name
Novartis Investigative Site #1
City
Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site #2
City
Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site #3
City
Ostrava
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Asslar
Country
Germany
Facility Name
Novartis Investigative Site
City
Bensheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Einbeck
Country
Germany
Facility Name
Novartis Investigative Site #1
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site #2
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site #3
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site #4
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site #1
City
Kassel
Country
Germany
Facility Name
Novartis Investigative Site #2
City
Kassel
Country
Germany
Facility Name
Novartis Investigative Site
City
Munchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Neubukow
Country
Germany
Facility Name
Novartis Investigative Site
City
Saarlouis
Country
Germany
Facility Name
Novartis Investigative Site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative Site #1
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site #2
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site #3
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site #4
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site #5
City
Guatemala City
Country
Guatemala
Facility Name
Novartis Investigative Site #1
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site #2
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site #1
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site #2
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Dunaujvaros
Country
Hungary
Facility Name
Novartis Investigative Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
Country
Hungary
Facility Name
Novartis Investigative Site
City
Indore
Country
India
Facility Name
Novartis Investigative Site
City
Jaipur
Country
India
Facility Name
Novartis Investigative Site
City
Karnal
Country
India
Facility Name
Novartis Investigative Site #2
City
Mumbai
Country
India
Facility Name
Novartis Investigative Site #1
City
Mumbia
Country
India
Facility Name
Novartis Investigative Site #1
City
Nagpur
Country
India
Facility Name
Novartis Investigative Site #2
City
Nagpur
Country
India
Facility Name
Novartis Investigative Site
City
Nasik
Country
India
Facility Name
Novartis Investigative Site #1
City
Trivandrum
Country
India
Facility Name
Novartis Investigative Site #2
City
Trivandrum
Country
India
Facility Name
Novartis Investigative Site
City
Alba-Iulia
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
Country
Romania
Facility Name
Novartis Investigative Site #1
City
Oradea
Country
Romania
Facility Name
Novartis Investigative Site #2
City
Oradea
Country
Romania
Facility Name
Novartis Investigative Site
City
Targu-Mures
Country
Romania
Facility Name
Novartis Investigative Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Novartis Investigative Site #1
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site #2
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site #3
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site #1
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigative Site #2
City
Kosice
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Presov
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Sturovo
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Carmarthen
Country
United Kingdom
Facility Name
Novartis Investigative Site #1
City
Glasgow
Country
United Kingdom
Facility Name
Novartis Investigative Site #2
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23961326
Citation
Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151.
Results Reference
result

Learn more about this trial

Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

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