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A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

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ClinicalTrials.gov Identifier: NCT00502710
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO4876904 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Dose-ranging Study of the Effect of DPP-IV on HbA1c, Other Efficacy Parameters, Pharmacokinetics and Safety in Patients With Type 2 Diabetes (BC20779)
Study Start Date : July 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RO4876904 1
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily.

Experimental: RO4876904 2
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily.

Experimental: RO4876904 3
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily.

Experimental: RO4876904 4
Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Drug: RO4876904
Escalating doses, at a starting dose of 12.5mg po daily.

Placebo Comparator: Placebo
Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Drug: Placebo
Placebo po daily.




Primary Outcome Measures :
  1. Absolute change in hemoglobin A1c (HbA1c) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. [ Time Frame: Week 12 ]
  2. Adverse events (AEs), vital signs, laboratory parameters. [ Time Frame: Throughout study ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 maximum tolerated dose (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502710


  Show 48 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502710     History of Changes
Other Study ID Numbers: BC20779
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

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