Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512108
• Other study ID #: NN2211-3924
• Secondary ID: U1111-1121-3457J
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2012
• Last updated: November 8, 2017
• Start date: January 10, 2012
• Est. completion date: April 26, 2013

Study information

• Verified date: November 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: April 26, 2013
• Est. primary completion date: April 26, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
• oral anti-diabetic drug
An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Chuo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Chuo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Ehime, Japan
Japan	Novo Nordisk Investigational Site	Fukuoka
Japan	Novo Nordisk Investigational Site	Fukuoka
Japan	Novo Nordisk Investigational Site	Fukuoka
Japan	Novo Nordisk Investigational Site	Fukuoka, Japan
Japan	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Kamagaya-shi, Chiba
Japan	Novo Nordisk Investigational Site	Kashiwara-shi, Osaka
Japan	Novo Nordisk Investigational Site	Kawagoe-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kitakyushu-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Koriyama-shi, Fukushima
Japan	Novo Nordisk Investigational Site	Kumamoto-shi,Kumamoto
Japan	Novo Nordisk Investigational Site	Kurume-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Miyazaki-shi
Japan	Novo Nordisk Investigational Site	Naka-shi, Ibaraki
Japan	Novo Nordisk Investigational Site	Niigata-shi, Niigata
Japan	Novo Nordisk Investigational Site	Oita
Japan	Novo Nordisk Investigational Site	Okawa-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Ota-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Oyama-shi, Tochigi
Japan	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Shimotsuke-shi, Tochigi
Japan	Novo Nordisk Investigational Site	Shizuoka-shi
Japan	Novo Nordisk Investigational Site	Tagajo-shi
Japan	Novo Nordisk Investigational Site	Takatsuki-shi, Osaka
Japan	Novo Nordisk Investigational Site	Tochigi
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Yamaguchi
Japan	Novo Nordisk Investigational Site	Yokohama-shi

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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, — View 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 r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (AEs)	Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.	Week 0 to Week 52 + 7 days
Secondary	Number of Confirmed Hypoglycaemic Episodes	Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).	Week 0 to Week 52
Secondary	Change in HbA1c From Baseline to Week 52	Estimated mean change in HbA1c from baseline after 52 Weeks of treatment	Week 0, week 52
Secondary	Change in FPG From Baseline to Week 52	Estimated mean change from baseline in FPG after 52 Weeks of treatment	Week 0, week 52

External Links

•   Clinical Trials at Novo Nordisk