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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00502710




Registration number
NCT00502710
Ethics application status
Date submitted
17/07/2007
Date registered
18/07/2007
Date last updated
5/08/2016

Titles & IDs
Public title
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
Scientific title
A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)
Secondary ID [1] 0 0
BC20779
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
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RO4876904

Experimental: RO4876904 1 - Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Experimental: RO4876904 2 - Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Experimental: RO4876904 3 - Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Experimental: RO4876904 4 - Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Placebo Comparator: Placebo - Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.


Treatment: Drugs: Placebo
Placebo po daily.

Treatment: Drugs: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily.

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

Outcomes
Primary outcome [1] 0 0
Absolute change in hemoglobin A1c (HbA1c)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Adverse events (AEs), vital signs, laboratory parameters.
Timepoint [2] 0 0
Throughout study

Eligibility
Key inclusion criteria
- adult patients, 18-75 years of age;

- type 2 diabetes diagnosed >= 1 month before screening;

- drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;

- BMI 25-45kg/m2.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- type 1 diabetes;

- any anti-hyperglycemic medication other than metformin, or weight-lowering drug,
during last 3 months.

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 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Canberra
Recruitment hospital [3] 0 0
- St. Leonards
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2605 - Canberra
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Guatemala
State/province [12] 0 0
Guatemala City
Country [13] 0 0
Hong Kong
State/province [13] 0 0
Hong Kong
Country [14] 0 0
Mexico
State/province [14] 0 0
Aguascalientes
Country [15] 0 0
Mexico
State/province [15] 0 0
Chihuahua
Country [16] 0 0
Mexico
State/province [16] 0 0
Guadalajara
Country [17] 0 0
Mexico
State/province [17] 0 0
Mexico City
Country [18] 0 0
Mexico
State/province [18] 0 0
Pachuca
Country [19] 0 0
Mexico
State/province [19] 0 0
Tampico
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Moscow
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Saratov
Country [22] 0 0
Russian Federation
State/province [22] 0 0
St Petersburg
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Yaroslavl
Country [24] 0 0
Spain
State/province [24] 0 0
Alzira
Country [25] 0 0
Spain
State/province [25] 0 0
Bacarot Alicant
Country [26] 0 0
Spain
State/province [26] 0 0
Badalona
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Ferrol
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Bath
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Frome
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Glasgow
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Liverpool
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Motherwell

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a
DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be
randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o.
Patients receiving metformin before the study will continue on the same dose of metformin.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.
Trial website
https://clinicaltrials.gov/show/NCT00502710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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
Other publications