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

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)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: RO4876904; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
  • Canberra, Australia, 2605
  • St. Leonards, Australia, 2065
• Brazil
  • Sao Paulo, Brazil, 01244-030
  • Sao Paulo, Brazil, 04022-001
• Guatemala
  • Guatemala City, Guatemala, 01015
• Hong Kong
  • Hong Kong, Hong Kong
• Mexico
  • Aguascalientes, Mexico, 20230
  • Chihuahua, Mexico, 31238
  • Guadalajara, Mexico, 44650
  • Guadalajara, Mexico, 45200
  • Mexico City, Mexico, 11650
  • Pachuca, Mexico, 42086
  • Tampico, Mexico, 89109
• Russian Federation
  • Moscow, Russian Federation, 129110
  • Moscow, Russian Federation, 117036
  • Moscow, Russian Federation, 109263
  • Moscow, Russian Federation, 125315
  • Moscow, Russian Federation, 121069
  • Saratov, Russian Federation, 410038
  • St Petersburg, Russian Federation, 197198
  • St Petersburg, Russian Federation, 197089
  • St Petersburg, Russian Federation, 195213
  • St Petersburg, Russian Federation, 195112
  • Yaroslavl, Russian Federation, 150062
  • Yaroslavl, Russian Federation, 150010
• Spain
  • Alzira, Spain, 46600
  • Bacarot Alicant, Spain, 03114
  • Badalona, Spain
  • Barcelona, Spain, 08022
  • Ferrol, Spain, 15405
• United Kingdom
  • Bath, United Kingdom, BA1 2SR
  • Frome, United Kingdom, BA11 1EZ
  • Glasgow, United Kingdom, G45 9AW
  • Liverpool, United Kingdom, L9 7AL
  • Motherwell, United Kingdom, ML1 3JX
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
  • California
    • Concord, California, United States, 94520
    • Los Angeles, California, United States, 90057
  • Illinois
    • Chicago, Illinois, United States, 60607
  • Indiana
    • Avon, Indiana, United States, 46123
    • Indianapolis, Indiana, United States, 46260
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
  • Michigan
    • Troy, Michigan, United States, 48098
  • Nebraska
    • Omaha, Nebraska, United States, 68154
  • New York
    • Binghamton, New York, United States, 13901
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in hemoglobin A1c (HbA1c)	Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: July 17, 2007
• First Submitted That Met QC Criteria: July 17, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BC20779