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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
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency
Trial website
https://clinicaltrials.gov/study/NCT00765830
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00765830