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: April 7, 2014
Last verified: April 2014
  Purpose

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability 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 and above), or placebo p.o. Patients receiving metformin before the study will continue 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: RO4876904
Drug: Placebo
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
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: April 7, 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 April 17, 2014