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

NCT ID: NCT01512108

Last Updated: 2017-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-10

Study Completion Date

2013-04-26

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide + an OAD therapy

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).

Two OADs combination therapy

Group Type ACTIVE_COMPARATOR

oral anti-diabetic drug

Intervention Type 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.

Interventions

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liraglutide

0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Ehime, Japan, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, Japan, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Kamagaya-shi, Chiba, , Japan

Site Status

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Kawagoe-shi, Saitama, , Japan

Site Status

Novo Nordisk Investigational Site

Kitakyushu-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Koriyama-shi, Fukushima, , Japan

Site Status

Novo Nordisk Investigational Site

Kumamoto-shi,Kumamoto, , Japan

Site Status

Novo Nordisk Investigational Site

Kurume-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Miyazaki, , Japan

Site Status

Novo Nordisk Investigational Site

Naka-shi, Ibaraki, , Japan

Site Status

Novo Nordisk Investigational Site

Niigata-shi, Niigata, , Japan

Site Status

Novo Nordisk Investigational Site

Okawa-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Osaka-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Osaka-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Ota-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Oyama-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Ōita, , Japan

Site Status

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Tagajō-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Yamaguchi, , Japan

Site Status

Novo Nordisk Investigational Site

Yokohama, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 26816604 (View on PubMed)

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.

Reference Type RESULT
PMID: 28984041 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1121-3457

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-121744

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN2211-3924

Identifier Type: -

Identifier Source: org_study_id