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A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

NCT ID: NCT02207374

Last Updated: 2019-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

601 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-04

Study Completion Date

2016-02-27

Brief Summary

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This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy.

All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

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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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Semaglutide 0.5 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.

Semaglutide 1.0 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.

One additional OAD + pre-trial treatment

The type and dosage of the additional OAD will be selected by the investigators according to the approved Japanese labelling including drug combinations and contraindications. One of DPP-4 inhibitor (dipeptidyl peptidase-4), SU (sulfonylurea), glinide, biguanide, α-GI (α-glucosidase inhibitor)or TZD (thiazolidinediones) will be selected as the additional OAD. For the subjects treated with OAD monotherapy as pre-trial treatment, the type and dosage of the additional OAD with a different mechanism of action from the pre-trial OAD should be chosen.

Group Type ACTIVE_COMPARATOR

DPP-4 inhibitor

Intervention Type DRUG

Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

Interventions

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semaglutide

Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.

Intervention Type DRUG

DPP-4 inhibitor

Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, age at least 20 years at the time of signing informed consent
* HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive)
* Japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before Visit 1 (week -2). or b) on OAD monotherapy (either of SU (sulfonylurea), glinide, a-GI (a-glucosidase inhibitor) or TZD (thiazolidinediones)) within approved Japanese labelling in addition to diet and exercise therapy for at least 60 days before Visit 1 (week -2)

* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value above or equal to 50 ng/L (pg/mL)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
* Acute coronary or cerebrovascular event within 90 days before randomisation (Visit 2 \[week 0\])
* Heart failure, New York Heart Association (NYHA) class IV

Exclusion Criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence \[not having sex\], diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period
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

Akita-shi, Akita, , Japan

Site Status

Novo Nordisk Investigational Site

Annaka-shi, Gunma, , Japan

Site Status

Novo Nordisk Investigational Site

Asahikawa-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Asahikawa-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Higashiosaka-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Izumisano, , Japan

Site Status

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Katsushika-ku, Tokyo, , 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

Kyoto-shi, Kyoto, , Japan

Site Status

Novo Nordisk Investigational Site

Mito-shi, Ibaraki, , 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

Nishinomiya-shi, Hygo, , Japan

Site Status

Novo Nordisk Investigational Site

Nishinomiya-shi, Hyogo, , Japan

Site Status

Novo Nordisk Investigational Site

Okawa-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Okayama-shi, Okayama, , 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

Ota-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Oyama-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Saga-shi,Saga, , 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

Sendai, , Japan

Site Status

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Suita-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Ube-shi, 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, Yamada Y, Watada H, Abiko A, Nishida T, Zacho J, Kiyosue A. Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial. Diabetes Obes Metab. 2018 May;20(5):1202-1212. doi: 10.1111/dom.13218. Epub 2018 Feb 21.

Reference Type RESULT
PMID: 29322610 (View on PubMed)

Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29748996 (View on PubMed)

Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29907893 (View on PubMed)

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1140-3081

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142640

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4091

Identifier Type: -

Identifier Source: org_study_id

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