Clinical trial NCT00111631: A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-05-25
Enrollment: 218
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute change from baseline in HbAlc\n
timeFrame: Week 16
Secondary outcomes:
measure: Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
timeFrame: Week 16
measure: AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
timeFrame: Throughout study
Other outcomes:
Locations:
city: Concord
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Diego
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Clearwater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Detroit
country: United States
state: Michigan
city: Buffalo
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Mogadore
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Connellsville
country: United States
state: Pennsylvania
city: Warminster
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Adelaide
country: Australia
city: Sydney
country: Australia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Bad Lauterberg
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Görlitz
country: Germany
city: Mainz
country: Germany
city: Neuss
country: Germany
city: Ancona
country: Italy
city: Firenze
country: Italy
city: Napoli
country: Italy
city: Udine
country: Italy
city: Ponce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: