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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00111631
First received: May 24, 2005
Last updated: April 7, 2014
Last verified: April 2014

May 24, 2005
April 7, 2014
May 2005
October 2006   (final data collection date for primary outcome measure)
Absolute change from baseline in HbAlc\n [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00111631 on ClinicalTrials.gov Archive Site
  • Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n [ Time Frame: Week 16 ] [ 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 Treated With a Stable Dose of Metformin

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable 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: DPP-IV Inhibitor
    Escalating doses po bid
  • Drug: Placebo
    po bid
  • Drug: Metformin
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: DPP-IV Inhibitor
    • Drug: Metformin
  • Experimental: 2
    Interventions:
    • Drug: DPP-IV Inhibitor
    • Drug: Metformin
  • Experimental: 3
    Interventions:
    • Drug: DPP-IV Inhibitor
    • Drug: Metformin
  • Placebo Comparator: 4
    Interventions:
    • Drug: Placebo
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients 18-75 years of age;
  • type 2 diabetes;
  • stable metformin therapy for >=3 months before screening.

Exclusion Criteria:

  • women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
  • type 1 diabetes;
  • any anti-hyperglycemic medication other than metformin in the last 3 months.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Germany,   Italy,   Puerto Rico
 
NCT00111631
BM18106
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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