NCT03172494|CompletedPhase 3ResultsFDA Drug

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

DUAL™ I China

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-4148U1111-1154-6671CTR20170004

Study Type

interventional

Target

720

Locations

1 country

Sites

Timeline

RegisteredJun 2017

StartedMay 2017

CompletionJul 2019

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

720

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2017

Longer than P75 for phase_3 diabetes

Geographic Reach

1 country

36 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

May 24, 2017

Completed

2 days until next milestone

Study Start

First participant enrolled

May 26, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2019

Completed

12 months until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed

Last Updated

December 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

May 24, 2017

Results QC Date

June 11, 2020

Last Update Submit

November 18, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.
Week 0, week 26

Secondary Outcomes (61)

Change in Body Weight
Week 0, week 26
Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes
Weeks 0-26
Insulin Dose
Week 26
Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)
Week 26
Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)
Week 26
+56 more secondary outcomes

Study Arms (3)

Insulin degludec/liraglutide

EXPERIMENTAL

Drug: Insulin degludec/liraglutide

Insulin degludec

ACTIVE COMPARATOR

Drug: Insulin degludec

Liraglutide

ACTIVE COMPARATOR

Drug: Liraglutide

Interventions

Insulin degludec/liraglutideDRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.

Insulin degludec/liraglutide

Insulin degludecDRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.

Insulin degludec

LiraglutideDRUG

Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. For 26 weeks.

Liraglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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)

Contact the study team to confirm eligibility.