Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
DRUG

Vildagliptin (LAF237)

Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily

DRUG

Placebo

Matching placebo of vildagliptin 50 mg twice daily

DRUG

Insulin

"Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.~The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion."

DRUG

Metformin

Patients continued their prescribed metformin dose, if applicable.

Trial Locations (31)

810-8798

Novartis Investigative Site, Fukuoka

815-0071

Novartis Investigative Site, Fukuoka

811-3217

Novartis Investigative Site, Fukutsu

800-0295

Novartis Investigative Site, Kitakyushu

963-8851

Novartis Investigative Site, Kōriyama

311-4153

Novartis Investigative Site, Mito

891-0401

Novartis Investigative Site, Ibusuki

221-0802

Novartis Investigative Site, Yokohama

861-8039

Novartis Investigative Site, Kumamoto

861-8520

Novartis Investigative Site, Kumamoto

866-8533

Novartis Investigative Site, Yatsushiro

615-0035

Novartis Investigative Site, Kyoto

980-0021

Novartis Investigative Site, Sendai

573-0153

Novartis Investigative Site, Hirakata

598-8577

Novartis Investigative Site, Izumisano

530-0001

Novartis Investigative Site, Osaka

534-0021

Novartis Investigative Site, Osaka

569-1096

Novartis Investigative Site, Takatsuki

362-8588

Novartis Investigative Site, Ageo

336-0963

Novartis Investigative Site, Saitama

350-1305

Novartis Investigative Site, Sayama

359-1161

Novartis Investigative Site, Tokorozawa

123-0845

Novartis Investigative Site, Adachi-ku

101-0024

Novartis Investigative Site, Chiyoda-ku

103-0027

Novartis Investigative Site, Chuo-ku

103-0028

Novartis Investigative Site, Chuo-ku

104-0061

Novartis Investigative Site, Chuo-ku

177-0041

Novartis Investigative Site, Nerima-ku

177-0051

Novartis Investigative Site, Nerima-ku

144-0051

Novartis Investigative Site, Ōta-ku

166-0004

Novartis Investigative Site, Suginami-ku

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY