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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/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
Sex
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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
289
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00502710