- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111631
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
November 1, 2016 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
218
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia, 5000
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Sydney, Australia, 2050
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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London, Ontario, Canada, NGA 4V2
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Toronto, Ontario, Canada, M5C 2T2
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Bad Lauterberg, Germany, 37431
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Berlin, Germany, 10115
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Dresden, Germany, 01307
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Görlitz, Germany, 02826
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Mainz, Germany, 55116
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Neuss, Germany, 41460
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Ancona, Italy, 60131
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Firenze, Italy, 50100
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Napoli, Italy, 80100
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Udine, Italy, 33100
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Ponce, Puerto Rico, 00716
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California
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Concord, California, United States, 94520
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Salinas, California, United States, 93901
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San Diego, California, United States, 92161
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Colorado
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Boulder, Colorado, United States, 80304
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Delaware
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Newark, Delaware, United States, 19713
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Wilmington, Delaware, United States, 19085
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Florida
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Clearwater, Florida, United States, 33765
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Miami, Florida, United States, 33156
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Illinois
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Chicago, Illinois, United States, 60607
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Michigan
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Detroit, Michigan, United States, 48202-2689
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New York
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Buffalo, New York, United States, 14209
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Rochester, New York, United States, 14609
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North Carolina
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Durham, North Carolina, United States, 27713
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Ohio
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Mogadore, Ohio, United States, 44260
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Oregon
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Portland, Oregon, United States, 97239
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Pennsylvania
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Connellsville, Pennsylvania, United States, 15425
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Warminster, Pennsylvania, United States, 18974
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Texas
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Dallas, Texas, United States, 75246
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Midland, Texas, United States, 79707
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San Antonio, Texas, United States, 78229
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients 18-75 years of age;
- type 2 diabetes;
- stable metformin therapy for >=3 months before screening.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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As prescribed
Escalating doses po bid
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Experimental: 2
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As prescribed
Escalating doses po bid
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Experimental: 3
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As prescribed
Escalating doses po bid
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Placebo Comparator: 4
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po bid
As prescribed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Absolute change from baseline in HbAlc\n
Time Frame: Week 16
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
Time Frame: Throughout study
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Throughout study
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Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
Time Frame: Week 16
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Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
May 24, 2005
First Submitted That Met QC Criteria
May 24, 2005
First Posted (Estimate)
May 25, 2005
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM18106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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