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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01224366




Registration number
NCT01224366
Ethics application status
Date submitted
18/10/2010
Date registered
20/10/2010
Date last updated
23/02/2017

Titles & IDs
Public title
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Scientific 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.
Secondary ID [1] 0 0
CLAF237A23135
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vildagliptin
Treatment: Drugs - Placebo

Experimental: Vildagliptin -

Placebo Comparator: Placebo -


Treatment: Drugs: Vildagliptin


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c reduction
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
HbA1c reduction in subpopulation treated with insulin and with metformin
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
HbA1c reduction in subpopulation treated with insulin and without metformin
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Reduction in FPG (overall and subpopulations)
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Responder rates (overall and subpopulations)
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)
Timepoint [5] 0 0
24 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
448
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg Heights
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [4] 0 0
Novartis Investigative Site #1 - Wollongong
Recruitment hospital [5] 0 0
Novartis Investigative Site #2 - Wollongong
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bonheiden
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
La Louviere
Country [5] 0 0
Belgium
State/province [5] 0 0
Ronse
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Ostrava
Country [7] 0 0
Germany
State/province [7] 0 0
Asslar
Country [8] 0 0
Germany
State/province [8] 0 0
Bensheim
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Einbeck
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Hannover
Country [13] 0 0
Germany
State/province [13] 0 0
Kassel
Country [14] 0 0
Germany
State/province [14] 0 0
Munchen
Country [15] 0 0
Germany
State/province [15] 0 0
Neubukow
Country [16] 0 0
Germany
State/province [16] 0 0
Saarlouis
Country [17] 0 0
Germany
State/province [17] 0 0
Tubingen
Country [18] 0 0
Guatemala
State/province [18] 0 0
Guatemala City
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Dunaujvaros
Country [22] 0 0
Hungary
State/province [22] 0 0
Nyiregyhaza
Country [23] 0 0
Hungary
State/province [23] 0 0
Szeged
Country [24] 0 0
India
State/province [24] 0 0
Indore
Country [25] 0 0
India
State/province [25] 0 0
Jaipur
Country [26] 0 0
India
State/province [26] 0 0
Karnal
Country [27] 0 0
India
State/province [27] 0 0
Mumbai
Country [28] 0 0
India
State/province [28] 0 0
Mumbia
Country [29] 0 0
India
State/province [29] 0 0
Nagpur
Country [30] 0 0
India
State/province [30] 0 0
Nasik
Country [31] 0 0
India
State/province [31] 0 0
Trivandrum
Country [32] 0 0
Romania
State/province [32] 0 0
Alba-Iulia
Country [33] 0 0
Romania
State/province [33] 0 0
Bucharest
Country [34] 0 0
Romania
State/province [34] 0 0
Oradea
Country [35] 0 0
Romania
State/province [35] 0 0
Targu-Mures
Country [36] 0 0
Slovakia
State/province [36] 0 0
Banska Bystrica
Country [37] 0 0
Slovakia
State/province [37] 0 0
Bratislava
Country [38] 0 0
Slovakia
State/province [38] 0 0
Kosice
Country [39] 0 0
Slovakia
State/province [39] 0 0
Presov
Country [40] 0 0
Slovakia
State/province [40] 0 0
Sturovo
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Carmarthen
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01224366
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01224366