A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

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

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-26

Study Completion Date

2019-07-13

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

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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Insulin degludec/liraglutide

Group Type EXPERIMENTAL

Insulin degludec/liraglutide

Intervention Type DRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

Insulin degludec

Group Type ACTIVE_COMPARATOR

Insulin degludec

Intervention Type DRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

Liraglutide

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

Interventions

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Insulin degludec/liraglutide

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

Intervention Type DRUG

Insulin degludec

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

Intervention Type DRUG

Liraglutide

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.

For 26 weeks.

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 are carried out as part of the trial, including activities to determine suitability for the trial
* Type 2 diabetes mellitus (clinically diagnosed)
* Male or female, age at least 18 years at the time of signing informed consent
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
* Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
* Metformin (above or equal to 1500 mg or max tolerated dose) or
* Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or
* Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or
* Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or
* Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)

Exclusion Criteria

* Treatment with insulin (except for short-term treatment at the discretion of the investigator)
* Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
* Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range
* Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin
* Screening calcitonin above or equal to 50 ng/L
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures
* Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg
* Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
* History of pancreatitis (acute or chronic)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Hefei, Anhui, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

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Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

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Novo Nordisk Investigational Site

Chongqing, Chongqing Municipality, China

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Novo Nordisk Investigational Site

Fuzhou, Fujian, China

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Novo Nordisk Investigational Site

Fuzhou, Fujian, China

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Novo Nordisk Investigational Site

Guangzhou, Guangdong, China

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Novo Nordisk Investigational Site

Guangzhou, Guangdong, China

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Novo Nordisk Investigational Site

Guangzhou, Guangdong, China

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Novo Nordisk Investigational Site

Cangzhou, Hebei, China

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Novo Nordisk Investigational Site

Shijiazhuang, Hebei, China

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Novo Nordisk Investigational Site

Shijiazhuang, Hebei, China

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Novo Nordisk Investigational Site

Changzhou, Jiangsu, China

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Novo Nordisk Investigational Site

Huai'an, Jiangsu, China

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Novo Nordisk Investigational Site

Huai'an, Jiangsu, China

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Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

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Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

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Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

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Novo Nordisk Investigational Site

Zhenjiang, Jiangsu, China

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Novo Nordisk Investigational Site

Nanchang, Jiangxi, China

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Novo Nordisk Investigational Site

Changchun, Jilin, China

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Novo Nordisk Investigational Site

Dalian, Liaoning, China

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Novo Nordisk Investigational Site

Yinchuan, Ningxia, China

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Novo Nordisk Investigational Site

Xi'an, Shaanxi, China

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Novo Nordisk Investigational Site

Jinan, Shandong, China

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