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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/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
Treatment: Drugs - Vildagliptin
Treatment: Drugs - Placebo

Experimental: 1 -

Placebo Comparator: 2 -


Treatment: Drugs: Vildagliptin


Treatment: Drugs: Placebo
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 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
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/ct2/show/NCT00646542
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/ct2/show/NCT00646542