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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00800176




Registration number
NCT00800176
Ethics application status
Date submitted
1/12/2008
Date registered
2/12/2008

Titles & IDs
Public title
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Scientific title
A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
2008-001249-24
Secondary ID [2] 0 0
BC21587
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 - RO4998452
Treatment: Drugs - RO4998452
Treatment: Drugs - RO4998452
Treatment: Drugs - RO4998452
Treatment: Drugs - RO4998452

Placebo comparator: Placebo - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.

During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.

Experimental: RO4998452 10mg - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.

Experimental: RO4998452 2.5mg - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.

Experimental: RO4998452 20mg - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.

Experimental: RO4998452 40mg - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.

Experimental: RO4998452 5mg - During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.


Treatment: Drugs: Placebo
po daily for 12 weeks

Treatment: Drugs: RO4998452
2.5mg po daily for 12 weeks

Treatment: Drugs: RO4998452
5mg po daily for 12 weeks

Treatment: Drugs: RO4998452
10mg po daily for 12 weeks

Treatment: Drugs: RO4998452
20mg po daily for 12 weeks

Treatment: Drugs: RO4998452
40mg po daily for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change in HbA1c
Timepoint [1] 0 0
Baseline, Week 4, Week 8 and Week 12
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (mmol/L)
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change From Baseline in Mean Daily Glucose Concentration (mmol/L)
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change From Baseline in Fructosamine Concentration (µmol/L)
Timepoint [3] 0 0
Baseline and 12 weeks
Secondary outcome [4] 0 0
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change From Baseline in Body Weight (kg)
Timepoint [7] 0 0
Baseline and Week 12
Secondary outcome [8] 0 0
Percentage of Participants Treated to Target HbA1c < 7%
Timepoint [8] 0 0
Baseline up to 12 weeks
Secondary outcome [9] 0 0
Percentage of Participants Treated to Target HbA1c < 6.5%
Timepoint [9] 0 0
Baseline up to 12 weeks
Secondary outcome [10] 0 0
Percentage of Participants With at Least One Adverse Event
Timepoint [10] 0 0
Baseline up to 12 weeks

Eligibility
Key inclusion criteria
* adult patients, 18-75 years of age;
* type 2 diabetes, diagnosed for >=3 months;
* either treated with diet, exercise and stable metformin, or with diet and exercise alone.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* type 1 diabetes mellitus;
* currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
* currently or within 6 months prior to screening treated with any PPARgamma agonist;
* uncontrolled hypertension;
* significant pre-diagnosed diabetic complications requiring treatment.

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
22/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/10/2009
Sample size
Target
Accrual to date
Final
394
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Brazil
State/province [10] 0 0
Fortaleza
Country [11] 0 0
Brazil
State/province [11] 0 0
Goiania
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Paulo
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Falkensee
Country [18] 0 0
Germany
State/province [18] 0 0
Luebeck
Country [19] 0 0
Germany
State/province [19] 0 0
Mainz
Country [20] 0 0
Germany
State/province [20] 0 0
Neuss
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Ibaraki
Country [24] 0 0
Japan
State/province [24] 0 0
Kanagawa
Country [25] 0 0
Japan
State/province [25] 0 0
Osaka
Country [26] 0 0
Japan
State/province [26] 0 0
Saitama
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Latvia
State/province [28] 0 0
Jelgava
Country [29] 0 0
Latvia
State/province [29] 0 0
Riga
Country [30] 0 0
Latvia
State/province [30] 0 0
Talsi
Country [31] 0 0
Latvia
State/province [31] 0 0
Valmiera
Country [32] 0 0
Mexico
State/province [32] 0 0
Chihuahua
Country [33] 0 0
Mexico
State/province [33] 0 0
Guadalajara
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico City
Country [35] 0 0
Romania
State/province [35] 0 0
Alba-iulia
Country [36] 0 0
Romania
State/province [36] 0 0
Brasov
Country [37] 0 0
Romania
State/province [37] 0 0
Bucharest
Country [38] 0 0
Romania
State/province [38] 0 0
Targu-mures
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Moscow
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Nizhny Novgorod
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Novosibirsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
S.petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saratov
Country [44] 0 0
Russian Federation
State/province [44] 0 0
St Petersburg
Country [45] 0 0
Russian Federation
State/province [45] 0 0
St. Petersburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Yaroslavl
Country [47] 0 0
Spain
State/province [47] 0 0
Alzira
Country [48] 0 0
Spain
State/province [48] 0 0
Lerida
Country [49] 0 0
Spain
State/province [49] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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 are available at https://clinicaltrials.gov/study/NCT00800176