Clinical trial NCT00502710: A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Absolute change in hemoglobin A1c (HbA1c)
timeFrame: Week 12
Secondary outcomes:
measure: Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.
timeFrame: Week 12
measure: Adverse events (AEs), vital signs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Concord
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Oxon Hill
country: United States
state: Maryland
city: Troy
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Binghamton
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Beaver
country: United States
state: Pennsylvania
city: Adelaide
country: Australia
city: Canberra
country: Australia
city: St. Leonards
country: Australia
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Guatemala City
country: Guatemala
city: Hong Kong
country: Hong Kong
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Pachuca
country: Mexico
city: Tampico
country: Mexico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Alzira
country: Spain
city: Bacarot Alicant
country: Spain
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Ferrol
country: Spain
city: Bath
country: United Kingdom
city: Frome
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Motherwell
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: