Clinical trial NCT01497522: Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin
Type 2 diabetes
HbA1c
Fasting plasma glucose
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 183
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
* HbA1c in the range of 7.0-10.0%
* Body mass index in the range 20-35 kg/m2

Exclusion Criteria:

* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
timeFrame: Baseline to 12 weeks
measure: Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of patients meeting Responder rates in HbA1c
timeFrame: 12 weeks
measure: Number of patients with adverse events (including hypoglycemia), serious adverse events and death
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kurume
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Ohkawa-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ageo-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 Mar 7.