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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00111631




Registration number
NCT00111631
Ethics application status
Date submitted
24/05/2005
Date registered
25/05/2005
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Scientific title
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin
Secondary ID [1] 0 0
BM18106
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 - DPP-IV Inhibitor
Treatment: Drugs - Metformin
Treatment: Drugs - Placebo

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Placebo Comparator: 4 -


Treatment: Drugs: DPP-IV Inhibitor
Escalating doses po bid

Treatment: Drugs: Metformin
As prescribed

Treatment: Drugs: Placebo
po bid

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

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in HbAlc\n
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
Timepoint [2] 0 0
Throughout study

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

- type 2 diabetes;

- stable metformin therapy for >=3 months before screening.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- women who are pregnant, breast-feeding, or not using an adequate contraceptive method;

- type 1 diabetes;

- any anti-hyperglycemic medication other than metformin in the 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
- Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
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
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
Manitoba
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Germany
State/province [16] 0 0
Bad Lauterberg
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Germany
State/province [19] 0 0
Görlitz
Country [20] 0 0
Germany
State/province [20] 0 0
Mainz
Country [21] 0 0
Germany
State/province [21] 0 0
Neuss
Country [22] 0 0
Italy
State/province [22] 0 0
Ancona
Country [23] 0 0
Italy
State/province [23] 0 0
Firenze
Country [24] 0 0
Italy
State/province [24] 0 0
Napoli
Country [25] 0 0
Italy
State/province [25] 0 0
Udine
Country [26] 0 0
Puerto Rico
State/province [26] 0 0
Ponce

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients
with type 2 diabetes receiving a stable 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/NCT00111631
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