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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502710

Enrollment

289

Registered

2007-07-18

Start date

2007-07-31

Completion date

2008-04-30

Last updated

2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGPlacebo

Placebo po daily.

DRUGRO4876904

Escalating doses, at a starting dose of 12.5mg po daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Brazil, Guatemala, Hong Kong, Mexico, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026