Clinical trial NCT01512108: Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Official title: A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 363
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
* Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
* Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
* HbA1c between 7.0-10.0% (both inclusive)
* Body Mass Index (BMI) below 40.0 kg/m\^2
* Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
* Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion Criteria:

* Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
* Calcitonin above or equal to 160 pg/mL
* Personal history of non-familial medullary thyroid carcinoma
* Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
* Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 52 + 7 days
Secondary outcomes:
measure: Number of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 52
measure: Change in HbA1c From Baseline to Week 52
timeFrame: Week 0, week 52
measure: Change in FPG From Baseline to Week 52
timeFrame: Week 0, week 52
Other outcomes:
Locations:
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ehime, Japan
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka, Japan
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kamagaya-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawagoe-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kitakyushu-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Koriyama-shi, Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Kurume-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Naka-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Niigata-shi, Niigata
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita
country: Japan
facility: Novo Nordisk Investigational Site
city: Okawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tagajo-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Takatsuki-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Yamaguchi
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kaku K, Kiyosue A, Ono Y, Shiraiwa T, Kaneko S, Nishijima K, Bosch-Traberg H, Seino Y. Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2016 Jan;7(1):76-84. doi: 10.1111/jdi.12367. Epub 2015 Jul 14.
citation: Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K. Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2018 Jul;9(4):831-839. doi: 10.1111/jdi.12759. Epub 2017 Nov 24.