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

July 17, 2007
August 26, 2014
July 2007
July 2008   (final data collection date for primary outcome measure)
Absolute change in HbAlc [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Absolute change in HbA1c from baseline to end of treatment
Complete list of historical versions of study NCT00502710 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Absolute change in FPG, HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. Safety: AEs, vital signs, lab tests, body weight, waist/hip ratio
Not Provided
Not Provided
 
A Study of DPP-IV (3) in Patients With Type 2 Diabetes.
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    po daily
  • Drug: RO4876904
    Escalating doses, at a starting dose of 12.5mg po daily
  • Experimental: 1
    Intervention: Drug: RO4876904
  • Experimental: 2
    Intervention: Drug: RO4876904
  • Experimental: 3
    Intervention: Drug: RO4876904
  • Experimental: 4
    Intervention: Drug: RO4876904
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Guatemala,   Hong Kong,   Mexico,   Russian Federation,   Spain,   United Kingdom
 
NCT00502710
BC20779
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP