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Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes

NCT ID: NCT01272193

Last Updated: 2017-03-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.

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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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IDegAsp OD

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).

insulin glargine

Intervention Type DRUG

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

IGlar OD

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Interventions

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insulin degludec/insulin aspart

Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).

Intervention Type DRUG

insulin glargine

Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
* Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)

Exclusion Criteria

* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
* Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
* Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
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

Asahikawa-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Chigasaki-shi, Kanagawa, , 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

Ebina-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Iruma-shi, Saitama, , Japan

Site Status

Novo Nordisk Investigational Site

Izumisano, , Japan

Site Status

Novo Nordisk Investigational Site

Kamakura-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Kanagawa-shi, Yokohama, , Japan

Site Status

Novo Nordisk Investigational Site

Kashiwa-shi, Chiba, , 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

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

Kumamoto-shi,Kumamoto, , Japan

Site Status

Novo Nordisk Investigational Site

Kurume-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Kurume-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Kyoto-shi, Kyoto, , Japan

Site Status

Novo Nordisk Investigational Site

Matsumoto-shi, Nagano, , Japan

Site Status

Novo Nordisk Investigational Site

Miyazaki, , Japan

Site Status

Novo Nordisk Investigational Site

Naha, , 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

Obihiro-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Obihiro-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Ogawa, , Japan

Site Status

Novo Nordisk Investigational Site

Okawa-shi, Fukuoka, , 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, Hokkaido, , 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

Sapporo-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Sappro-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Sasebo-shi, Nagasaki, , 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

Shizuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Tagajō-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Tagawa-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Takatsuki-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Tamana-shi, Kumamoto, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tsuchiura-shi, Ibaraki, , Japan

Site Status

Novo Nordisk Investigational Site

Urasoe-shi,, , Japan

Site Status

Novo Nordisk Investigational Site

Yokohama-shi, Kanagawa, , Japan

Site Status

Countries

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Japan

References

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Onishi Y, Ono Y, Rabol R, Endahl L, Nakamura S. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013 Sep;15(9):826-32. doi: 10.1111/dom.12097. Epub 2013 Apr 5.

Reference Type RESULT
PMID: 23557077 (View on PubMed)

Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

Reference Type DERIVED
PMID: 35044568 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1118-0124

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-111385

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN5401-3896

Identifier Type: -

Identifier Source: org_study_id

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