search
Back to results

Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vildagliptin + metformin
metformin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of T2DM treated with Metformin

Exclusion Criteria:

  • FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Cabinet d'Endocrinologie-Maladies Métaboliques
  • Service Endocrinologic & Metabolisme
  • Polycliniques des minguettes
  • Hausärztliche Praxis
  • Klinische Forschung Berlin Mitte GmbH
  • AVK
  • Gemeinschaftspraxis
  • Malteser KM
  • Untertrintroper Hausarztzentrum
  • Diabeteszentrum Billstedt/Horn
  • Diabetologische Schwerpunktpraxis
  • St. Elisabeth Krankenhaus Leipzig
  • Diabetes-Schwerpunktpraxis Studienambulanz
  • Institut für Diabetes-forschung Münster
  • Praxis Dr. Alawi
  • DDT
  • Diabetologische Schwerpunktpraxis
  • Praxis
  • Synexus Magyarorszag
  • Uzsoki Hospital
  • Europ-Med Orvosi Szolgaltato Kft
  • Kenezy Hospital
  • Gyngyosi Korhaz Kft
  • Petz Aladar County
  • Selye Janos Korhaz es Rendelointezet
  • DIAPED Kft., MRC
  • Josa Andras Teaching Hospital
  • Vas Megyei Markuscvszky Lajos Korhaz
  • Zala County Hospital
  • NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
  • Gdanska Poradnia Cukrzycowa
  • Gabinet Kardiologiczny Mediplus
  • NZOZ "Esculap" S.C.
  • SZPZOZ Szpital Zachodni im. Jana Pawla II
  • NZOZ Terapia Optima
  • Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
  • Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
  • Instytut Cantrum Zdrowia Matki Polki
  • NZOZ Special-Med
  • Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
  • Lecznica Prosen-SMO NZOZ
  • Centrum Leczenia Chorob Cywilizacyjnych
  • NZCZ Regionalna Poradnia Diabetologiczna
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vildagliptin + metformin

metformin

Arm Description

Outcomes

Primary Outcome Measures

HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy

Secondary Outcome Measures

FPG reduction
Safety and tolerability
Body weight change from baseline
Changes in the fasting lipid profile

Full Information

First Posted
July 31, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00728351
Brief Title
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
Official Title
A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

6. Conditions and Keywords

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

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
Arm Type
Experimental
Arm Title
metformin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
vildagliptin + metformin
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
1000 bid metformin
Primary Outcome Measure Information:
Title
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
FPG reduction
Time Frame
24 weeks
Title
Safety and tolerability
Time Frame
24 weeks
Title
Body weight change from baseline
Time Frame
24 weeks
Title
Changes in the fasting lipid profile
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of T2DM treated with Metformin Exclusion Criteria: FPG >= 260 mg/dL (14.4mmol/L) 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:
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Novartis Investigative Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28409
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Uniontown
State/Province
Pennsylvania
Country
United States
City
Taylors
State/Province
South Carolina
ZIP/Postal Code
29687
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77023
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Cabinet d'Endocrinologie-Maladies Métaboliques
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Service Endocrinologic & Metabolisme
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Polycliniques des minguettes
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Hausärztliche Praxis
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinische Forschung Berlin Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
AVK
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
Malteser KM
City
Duisburg
ZIP/Postal Code
42259
Country
Germany
Facility Name
Untertrintroper Hausarztzentrum
City
Essen
ZIP/Postal Code
45359
Country
Germany
City
Gefrees
ZIP/Postal Code
95482
Country
Germany
Facility Name
Diabeteszentrum Billstedt/Horn
City
Hamburg
ZIP/Postal Code
22119
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis
City
Hamburg
ZIP/Postal Code
22119
Country
Germany
Facility Name
St. Elisabeth Krankenhaus Leipzig
City
Leipzig
ZIP/Postal Code
04229
Country
Germany
Facility Name
Diabetes-Schwerpunktpraxis Studienambulanz
City
Leipzig
ZIP/Postal Code
04257
Country
Germany
Facility Name
Institut für Diabetes-forschung Münster
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Praxis Dr. Alawi
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
DDT
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis
City
Sinsheim
ZIP/Postal Code
74889
Country
Germany
Facility Name
Praxis
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Synexus Magyarorszag
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Uzsoki Hospital
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Budapest
Country
Hungary
Facility Name
Europ-Med Orvosi Szolgaltato Kft
City
Budaörs
ZIP/Postal Code
2040
Country
Hungary
Facility Name
Kenezy Hospital
City
Debrecen
Country
Hungary
Facility Name
Gyngyosi Korhaz Kft
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Petz Aladar County
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Selye Janos Korhaz es Rendelointezet
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
DIAPED Kft., MRC
City
Meggyesalja U.
ZIP/Postal Code
122
Country
Hungary
Facility Name
Josa Andras Teaching Hospital
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Vas Megyei Markuscvszky Lajos Korhaz
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Zala County Hospital
City
Zalaegerszeg
Country
Hungary
Facility Name
NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Gdanska Poradnia Cukrzycowa
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Gabinet Kardiologiczny Mediplus
City
Gdynia
ZIP/Postal Code
81-423
Country
Poland
Facility Name
NZOZ "Esculap" S.C.
City
Gniewkowo
ZIP/Postal Code
88-140
Country
Poland
Facility Name
SZPZOZ Szpital Zachodni im. Jana Pawla II
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
NZOZ Terapia Optima
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
City
Leczyca
ZIP/Postal Code
99-100
Country
Poland
Facility Name
Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
City
Leczyca
ZIP/Postal Code
99-100
Country
Poland
Facility Name
Instytut Cantrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
NZOZ Special-Med
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Lecznica Prosen-SMO NZOZ
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Centrum Leczenia Chorob Cywilizacyjnych
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
NZCZ Regionalna Poradnia Diabetologiczna
City
Wroclaw
ZIP/Postal Code
50-127
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com
Description
Click here for more information on the clinical study
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3860
Description
Results for CLMF237A2309 from the Novartis Clinical Trials website

Learn more about this trial

Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

We'll reach out to this number within 24 hrs