NCT03175120|CompletedPhase 3ResultsFDA Drug

A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)

DUAL™ II China

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-4166U1111-1154-6732CTR20060909

Study Type

interventional

Target

453

Locations

2 countries

Sites

Timeline

RegisteredJun 2017

StartedMay 2017

CompletionApr 2019

Brief Summary

This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment

Trial Health

On Track

Trial Health Score

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

Enrollment

453

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started May 2017

Typical duration for phase_3 diabetes

Geographic Reach

2 countries

37 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

1.9 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

10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed

12 months until next milestone

Results Posted

Study results publicly available

March 19, 2020

Completed

Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

May 24, 2017

Results QC Date

February 26, 2020

Last Update Submit

March 18, 2020

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.
Week 0, week 26

Secondary Outcomes (60)

Change in Body Weight
Week 0, week 26
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Up to 26 weeks
Change in Fasting Plasma Glucose (FPG)
Week 0, week 26
Change in Waist Circumference
Week 0, week 26
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile
Week 0, week 26
+55 more secondary outcomes

Study Arms (2)

Insulin degludec/liraglutide

EXPERIMENTAL

Drug: Insulin degludec/liraglutide

Insulin degludec

ACTIVE COMPARATOR

Drug: Insulin degludec

Interventions

Insulin degludec/liraglutideDRUG

Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

Insulin degludec/liraglutide

Insulin degludecDRUG

Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

Insulin degludec

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.