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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01233622




Registration number
NCT01233622
Ethics application status
Date submitted
1/11/2010
Date registered
3/11/2010
Date last updated
23/02/2017

Titles & IDs
Public title
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Scientific 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
Secondary ID [1] 0 0
EudraCT 2010-021097-11
Secondary ID [2] 0 0
CLAF237A23152
Universal Trial Number (UTN)
Trial acronym
Vildagliptin
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
Experimental: Vildagliptin (metformin + glimepiride) -

Placebo comparator: Placebo (metformin + glimepiride) -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c Reduction
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
FPG reduction
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Responder Rate
Timepoint [3] 0 0
24 weeks

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

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 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
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
317
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
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [4] 0 0
Novartis Investigative Site - St. Leonards
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- St. Leonards
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Anderbeck
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg
Country [4] 0 0
Germany
State/province [4] 0 0
Hildesheim
Country [5] 0 0
Germany
State/province [5] 0 0
Sangerhausen
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
Hungary
State/province [7] 0 0
Erd
Country [8] 0 0
Hungary
State/province [8] 0 0
Torokbalint
Country [9] 0 0
Italy
State/province [9] 0 0
Bergamo
Country [10] 0 0
Italy
State/province [10] 0 0
Cosenza
Country [11] 0 0
Italy
State/province [11] 0 0
Milano
Country [12] 0 0
Italy
State/province [12] 0 0
Padova
Country [13] 0 0
Italy
State/province [13] 0 0
Pisa
Country [14] 0 0
Italy
State/province [14] 0 0
Roma
Country [15] 0 0
Italy
State/province [15] 0 0
Torino
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Bundang
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Suwon
Country [19] 0 0
Mexico
State/province [19] 0 0
Aguascalientes
Country [20] 0 0
Mexico
State/province [20] 0 0
Durango
Country [21] 0 0
Mexico
State/province [21] 0 0
Guadalajara
Country [22] 0 0
Mexico
State/province [22] 0 0
Mexico
Country [23] 0 0
Mexico
State/province [23] 0 0
Pachuca
Country [24] 0 0
Philippines
State/province [24] 0 0
Manila
Country [25] 0 0
Philippines
State/province [25] 0 0
Quezon City
Country [26] 0 0
Romania
State/province [26] 0 0
Alba-Iulia
Country [27] 0 0
Romania
State/province [27] 0 0
Bucharest
Country [28] 0 0
Romania
State/province [28] 0 0
Oradea
Country [29] 0 0
Romania
State/province [29] 0 0
Targu-Mures
Country [30] 0 0
Taiwan
State/province [30] 0 0
Changhua
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taichung
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taipei
Country [33] 0 0
Taiwan
State/province [33] 0 0
Yongkang

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01233622
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01233622