A Study of DPP-IV (3) in Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502710
First received: July 17, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerabi lity 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 a nd above), or placebo p.o. Patients receiving metformin before the study will co ntinue 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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: RO4876904
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV (3) on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change in HbAlc [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in FPG, HbAlc response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • AEs, vital signs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily
Experimental: 2 Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily
Experimental: 3 Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily
Experimental: 4 Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily
Placebo Comparator: 5 Drug: Placebo
po daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes diagnosed >= 1 month before screening;
  • drug-naive, or pretreated with MTD of metformin;
  • BMI 25-45kg/m2.

Exclusion Criteria:

  • type 1 diabetes;
  • any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502710

  Hide Study Locations
Locations
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Concord, California, United States, 94520
Los Angeles, California, United States, 90057
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Avon, Indiana, United States, 46123
Indianapolis, Indiana, United States, 46260
United States, Maryland
Oxon Hill, Maryland, United States, 20745
United States, Michigan
Troy, Michigan, United States, 48098
United States, Nebraska
Omaha, Nebraska, United States, 68154
United States, New York
Binghamton, New York, United States, 13901
United States, North Carolina
Charlotte, North Carolina, United States, 28211
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
Australia
Adelaide, Australia, 5000
Canberra, Australia, 2605
St. Leonards, Australia, 2065
Brazil
Sao Paulo, Brazil, 04022-001
Sao Paulo, Brazil, 01244-030
Guatemala
Guatemala City, Guatemala, 01015
Hong Kong
Hong Kong, Hong Kong
Mexico
Aguascalientes, Mexico, 20230
Chihuahua, Mexico, 31238
Guadalajara, Mexico, 44650
Guadalajara, Mexico, 45200
Mexico City, Mexico, 11650
Pachuca, Mexico, 42086
Tampico, Mexico, 89109
Russian Federation
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 121069
Moscow, Russian Federation, 109263
Moscow, Russian Federation, 125315
Saratov, Russian Federation, 410038
St Petersburg, Russian Federation, 195213
St Petersburg, Russian Federation, 197198
St Petersburg, Russian Federation, 195112
St Petersburg, Russian Federation, 197089
Yaroslavl, Russian Federation, 150062
Yaroslavl, Russian Federation, 150010
Spain
Alzira, Spain, 46600
Bacarot Alicant, Spain, 03114
Badalona, Spain
Barcelona, Spain, 08022
Ferrol, Spain, 15405
United Kingdom
Bath, United Kingdom, BA1 2SR
Frome, United Kingdom, BA11 1EZ
Glasgow, United Kingdom, G45 9AW
Liverpool, United Kingdom, L9 7AL
Motherwell, United Kingdom, ML1 3JX
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502710     History of Changes
Other Study ID Numbers: BC20779
Study First Received: July 17, 2007
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 15, 2014