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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00765830




Registration number
NCT00765830
Ethics application status
Date submitted
2/10/2008
Date registered
3/10/2008
Date last updated
17/12/2020

Titles & IDs
Public title
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
Scientific title
A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Secondary ID [1] 0 0
CLAF237A23137E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Renal Insufficiency 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
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: 1 - 50mg qd vildagliptin

Placebo comparator: 2 - Placebo


Treatment: Drugs: vildagliptin
50mg qd

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

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency
Timepoint [1] 0 0
52 weeks

Eligibility
Key inclusion criteria
* Complete the core study
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Did not comply with core study requirements

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 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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
349
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 0 0
Heidelberg Repatriation Hospital - Heidelberg Heights
Recruitment hospital [3] 0 0
SA Endocrine Clinical Research - Keswick
Recruitment hospital [4] 0 0
Keogh Medical Research Institute - Nedlands Perth
Recruitment hospital [5] 0 0
St Vincent's Hospital (Melb) - Victoria
Recruitment postcode(s) [1] 0 0
- Woodville
Recruitment postcode(s) [2] 0 0
- Heidelberg Heights
Recruitment postcode(s) [3] 0 0
- Keswick
Recruitment postcode(s) [4] 0 0
- Nedlands Perth
Recruitment postcode(s) [5] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Corrientes
Country [4] 0 0
Argentina
State/province [4] 0 0
San Miguel de Tucuman
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Laval
Country [10] 0 0
Canada
State/province [10] 0 0
Winnipeg
Country [11] 0 0
Costa Rica
State/province [11] 0 0
Cartago
Country [12] 0 0
Costa Rica
State/province [12] 0 0
San Jose
Country [13] 0 0
Finland
State/province [13] 0 0
Pori
Country [14] 0 0
Finland
State/province [14] 0 0
Seinajoki
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
France
State/province [16] 0 0
Angers
Country [17] 0 0
France
State/province [17] 0 0
Boulogne-sur-Mer
Country [18] 0 0
France
State/province [18] 0 0
Grenoble cedex 9
Country [19] 0 0
France
State/province [19] 0 0
Laval
Country [20] 0 0
France
State/province [20] 0 0
Limoges Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lyon
Country [22] 0 0
Germany
State/province [22] 0 0
Augsburg
Country [23] 0 0
Germany
State/province [23] 0 0
Bad Kreuznach
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Darmstadt
Country [26] 0 0
Germany
State/province [26] 0 0
Dormagen
Country [27] 0 0
Germany
State/province [27] 0 0
Erlangen
Country [28] 0 0
Germany
State/province [28] 0 0
Frankfurt
Country [29] 0 0
Germany
State/province [29] 0 0
Hannover
Country [30] 0 0
Germany
State/province [30] 0 0
Jena
Country [31] 0 0
Germany
State/province [31] 0 0
Kiel
Country [32] 0 0
Germany
State/province [32] 0 0
Meissen
Country [33] 0 0
Germany
State/province [33] 0 0
Muenchen
Country [34] 0 0
Germany
State/province [34] 0 0
München
Country [35] 0 0
Germany
State/province [35] 0 0
Nuernberg
Country [36] 0 0
Germany
State/province [36] 0 0
Witten
Country [37] 0 0
Germany
State/province [37] 0 0
Wuerzburg
Country [38] 0 0
India
State/province [38] 0 0
Ahmedabad
Country [39] 0 0
India
State/province [39] 0 0
Chennai
Country [40] 0 0
India
State/province [40] 0 0
Coimbatore
Country [41] 0 0
India
State/province [41] 0 0
Jaipur
Country [42] 0 0
India
State/province [42] 0 0
Madurai
Country [43] 0 0
India
State/province [43] 0 0
Nagpur
Country [44] 0 0
Norway
State/province [44] 0 0
Oslo
Country [45] 0 0
Norway
State/province [45] 0 0
Trondheim
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Chelyabinsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Moscow
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Saint Petersburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Saint-Petersburg
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Smolensk
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Tyumen
Country [52] 0 0
Spain
State/province [52] 0 0
Alicante
Country [53] 0 0
Spain
State/province [53] 0 0
Alzira
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Begonte
Country [56] 0 0
Spain
State/province [56] 0 0
Caceres
Country [57] 0 0
Spain
State/province [57] 0 0
Cordoba
Country [58] 0 0
Spain
State/province [58] 0 0
Hospitalet de Llobregat
Country [59] 0 0
Spain
State/province [59] 0 0
Jerez de La Frontera
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Merida
Country [62] 0 0
Spain
State/province [62] 0 0
Palma De Mallorca
Country [63] 0 0
Spain
State/province [63] 0 0
Sabadell
Country [64] 0 0
Spain
State/province [64] 0 0
Santiago de Compostela
Country [65] 0 0
Spain
State/province [65] 0 0
Vic
Country [66] 0 0
Sweden
State/province [66] 0 0
Goteborg
Country [67] 0 0
Sweden
State/province [67] 0 0
Kristianstad
Country [68] 0 0
Sweden
State/province [68] 0 0
Lund
Country [69] 0 0
Sweden
State/province [69] 0 0
Skene

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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 not provided in https://clinicaltrials.gov/study/NCT00765830