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Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride (Vildagliptin)

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

Eligibility Criteria

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

Inclusion criteria

  • Confirmed diagnosis of T2DM by standard criteria.
  • Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
  • Age: ≥18 to ≤ 80 years
  • HbA1c of ≥ 7.5 and ≤ 11.0%
  • Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

  • FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
  • Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
  • Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin (metformin + glimepiride)

Placebo (metformin + glimepiride)

Arm Description

Outcomes

Primary Outcome Measures

HbA1c Reduction

Secondary Outcome Measures

FPG reduction
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
Responder Rate

Full Information

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

Unique Protocol Identification Number
NCT01233622
Brief Title
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Acronym
Vildagliptin
Official Title
A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin (metformin + glimepiride)
Arm Type
Experimental
Arm Title
Placebo (metformin + glimepiride)
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
FPG reduction
Time Frame
24 weeks
Title
Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs)
Time Frame
24 weeks
Title
Responder Rate
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 by standard criteria. Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides Age: ≥18 to ≤ 80 years HbA1c of ≥ 7.5 and ≤ 11.0% Body Mass Index (BMI) ≥22 to ≤45 kg/m2 Exclusion criteria: FPG ≥ 270 mg/dL (≥ 15.0 mmol/L) Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes Acute infections which may affect blood glucose control within 4 weeks prior to screening 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
Facility Information:
Facility Name
Novartis Investigative Site
City
Box Hill
Country
Australia
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Australia
Facility Name
Novartis Investigative Site
City
Parkville
Country
Australia
Facility Name
Novartis Investigative Site
City
St. Leonards
Country
Australia
Facility Name
Novartis Investigative Site
City
Anderbeck
Country
Germany
Facility Name
Novartis Investigative Site #1
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site #2
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site #3
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site #4
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Hildesheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Sangerhausen
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Erd
Country
Hungary
Facility Name
Novartis Investigative Site
City
Torokbalint
Country
Hungary
Facility Name
Novartis Investigative Site
City
Bergamo
Country
Italy
Facility Name
Novartis Investigative Site
City
Cosenza
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
Country
Italy
Facility Name
Novartis Investigative Site #1
City
Roma
Country
Italy
Facility Name
Novartis Investigative Site #2
City
Roma
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
Country
Italy
Facility Name
Novartis Investigative Site
City
Bundang
Country
Korea, Republic of
Facility Name
Novartis Investigative Site #1
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site #2
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site #3
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
Country
Korea, Republic of
Facility Name
Novartis Investigative Site #1
City
Aguascalientes
Country
Mexico
Facility Name
Novartis Investigative Site #2
City
Aguascalientes
Country
Mexico
Facility Name
Novartis Investigative Site #3
City
Aguascalientes
Country
Mexico
Facility Name
Novartis Investigative Site #1
City
Durango
Country
Mexico
Facility Name
Novartis Investigative Site #2
City
Durango
Country
Mexico
Facility Name
Novartis Investigative Site #3
City
Durango
Country
Mexico
Facility Name
Novartis Investigative Site #1
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigative Site #2
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigative Site #3
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigative Site #4
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigative Site #5
City
Guadalajara
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
Country
Mexico
Facility Name
Novartis Investigative Site #1
City
Pachuca
Country
Mexico
Facility Name
Novartis Investigative Site #2
City
Pachuca
Country
Mexico
Facility Name
Novartis Investigative Site #3
City
Pachuca
Country
Mexico
Facility Name
Novartis Investigative Site
City
Manila
Country
Philippines
Facility Name
Novartis Investigative Site #1
City
Quezon City
Country
Philippines
Facility Name
Novartis Investigative Site #2
City
Quezon City
Country
Philippines
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
Changhua
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Yongkang
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24199686
Citation
Lukashevich V, Del Prato S, Araga M, Kothny W. Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea. Diabetes Obes Metab. 2014 May;16(5):403-9. doi: 10.1111/dom.12229. Epub 2013 Dec 2.
Results Reference
result

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Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

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