Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 24, 2005
Last updated: February 5, 2015
Last verified: February 2015

May 24, 2005
February 5, 2015
June 2005
July 2006   (final data collection date for primary outcome measure)
Absolute change from baseline in HbAlc\n\n [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00111670 on Archive Site
  • Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Not Provided
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: DPP-IV Inhibitor
    Escalating doses po bid or qd
  • Drug: Placebo
    po bid or qd
  • Experimental: 1
    Intervention: Drug: DPP-IV Inhibitor
  • Experimental: 2
    Intervention: Drug: DPP-IV Inhibitor
  • Experimental: 3
    Intervention: Drug: DPP-IV Inhibitor
  • Experimental: 4
    Intervention: Drug: DPP-IV Inhibitor
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2006
July 2006   (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;
  • no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

  • type 1 diabetes;
  • type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
  • patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
18 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Costa Rica,   Estonia,   Latvia,   Lithuania,   Mexico,   Puerto Rico,   Romania
Puerto Rico
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2015

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