Clinical trial NCT00111670: 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
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: 291
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 compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 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;
* no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

* type 1 diabetes;
* type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
* patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Primary outcomes:
measure: Absolute change from baseline in HbAlc\n\n
timeFrame: Week 12
Secondary outcomes:
measure: Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate
timeFrame: Week 12
measure: AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
timeFrame: Throughout study
Other outcomes:
Locations:
city: Salinas
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Blue Ridge
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Elkton
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Troy
country: United States
state: Michigan
city: Pahrump
country: United States
state: Nevada
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
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: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: San Jose
country: Costa Rica
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Ogre
country: Latvia
city: Riga
country: Latvia
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Ponce
country: Puerto Rico
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Ploiesti
country: Romania
city: Tirgu-mures
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: