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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: November 3, 2014
Last verified: November 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

  Show 48 Study Locations
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: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014