A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

458

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
DiabetesDiabetes Mellitus, Type 2
Interventions
DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

DRUG

insulin degludec

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Trial Locations (40)

103 0002

Novo Nordisk Investigational Site, Chuo-ku, Tokyo

103 0027

Novo Nordisk Investigational Site, Chuo-ku, Tokyo

918-8503

Novo Nordisk Investigational Site, Fukui-shi, Fukui

812 0025

Novo Nordisk Investigational Site, Fukuoka

501-1194

Novo Nordisk Investigational Site, Gifu-shi, Gifu

598 0048

Novo Nordisk Investigational Site, Izumisano

890-8520

Novo Nordisk Investigational Site, Kagoshima-shi, Kagoshima

247 0056

Novo Nordisk Investigational Site, Kamakura-shi

582 0005

Novo Nordisk Investigational Site, Kashiwara-shi, Osaka

125 0054

Novo Nordisk Investigational Site, Katsushika-ku, Tokyo

216-8511

Novo Nordisk Investigational Site, Kawasaki-shi, Kanagawa

800 0252

Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka

807-8555

Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka

800-0222

Novo Nordisk Investigational Site, Kitakyusyu-shi, Fukuoka

963 8851

Novo Nordisk Investigational Site, Koriyama-shi, Fukushima

862 0976

Novo Nordisk Investigational Site, Kumamoto-shi,Kumamoto

310-0845

Novo Nordisk Investigational Site, Mito-shi, Ibaraki

880 0034

Novo Nordisk Investigational Site, Miyazaki

311 0113

Novo Nordisk Investigational Site, Naka-shi, Ibaraki

951-8520

Novo Nordisk Investigational Site, Niigata-shi, Niigata

663-8501

Novo Nordisk Investigational Site, Nishinomiya-shi, Hyogo

831 0016

Novo Nordisk Investigational Site, Okawa-shi, Fukuoka

532 0003

Novo Nordisk Investigational Site, Osaka-shi, Osaka

323 0022

Novo Nordisk Investigational Site, Oyama-shi, Tochigi

870 0039

Novo Nordisk Investigational Site, Ōita

762-0031

Novo Nordisk Investigational Site, Sakaide-shi, Kagawa

060 0062

Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido

060-0001

Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido

062 0007

Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido

980 0021

Novo Nordisk Investigational Site, Sendai

329 0433

Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi

565-0853

Novo Nordisk Investigational Site, Suita-shi, Osaka

569 1096

Novo Nordisk Investigational Site, Takatsuki-shi, Osaka

103-0028

Novo Nordisk Investigational Site, Tokyo

113-8655

Novo Nordisk Investigational Site, Tokyo

123-0845

Novo Nordisk Investigational Site, Tokyo

143-8541

Novo Nordisk Investigational Site, Tokyo

144-0051

Novo Nordisk Investigational Site, Tokyo

162-8655

Novo Nordisk Investigational Site, Tokyo

510-0829

Novo Nordisk Investigational Site, Yokkaichi-shi, Mie

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01880736 - A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes | Biotech Hunter | Biotech Hunter