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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00646542




Registration number
NCT00646542
Ethics application status
Date submitted
24/03/2008
Date registered
28/03/2008
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
Scientific title
A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Secondary ID [1] 0 0
CLAF237A23137
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 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
Experimental: 1 -

Placebo comparator: 2 -

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 24 weeks of treatment
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.
Timepoint [2] 0 0
24 weeks

Eligibility
Key inclusion criteria
* History T2DM
* Moderate or Severe Renal Impairment
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Glucose > 270 mg/dL (>15 mmol/L)

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 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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
525
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Heidelberg Heights
Recruitment postcode(s) [1] 0 0
- Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Canada
State/province [2] 0 0
Winnipeg
Country [3] 0 0
Costa Rica
State/province [3] 0 0
Cartago
Country [4] 0 0
Finland
State/province [4] 0 0
Tampere
Country [5] 0 0
France
State/province [5] 0 0
Angers
Country [6] 0 0
Germany
State/province [6] 0 0
Dormagen
Country [7] 0 0
India
State/province [7] 0 0
Chennai
Country [8] 0 0
Norway
State/province [8] 0 0
Oslo
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Saint Petersburg
Country [10] 0 0
Spain
State/province [10] 0 0
Alicante
Country [11] 0 0
Sweden
State/province [11] 0 0
Lund

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/NCT00646542