NCT01392573|CompletedPhase 3Results

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes

DUAL™ II

A 26-week Randomised, Parallel Two-arm, Double-blind, Multi-centre, Multinational, Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide With Insulin Degludec in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-39122011-002336-72U1111-1121-4897

Study Type

interventional

Target

413

Locations

7 countries

Sites

Timeline

RegisteredJul 2011

StartedNov 2011

CompletionOct 2012

Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

413

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Nov 2011

Shorter than P25 for phase_3 diabetes

Geographic Reach

7 countries

86 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

10 months study duration

First Submitted

Initial submission to the registry

July 7, 2011

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed

5 months until next milestone

Study Start

First participant enrolled

November 28, 2011

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed

3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2012

Completed

4.3 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed

Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

July 7, 2011

Results QC Date

November 23, 2016

Last Update Submit

December 7, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
Week 0, week 26

Secondary Outcomes (1)

Change in Body Weight
Week 0, week 26

Study Arms (2)

IDegLira + metformin

EXPERIMENTAL

IDegLira was injected subcutaneously once daily for 26 weeks.

Drug: insulin degludec/liraglutide

IDeg + metformin

EXPERIMENTAL

IDeg was injected subcutaneously once daily for 26 weeks.

Drug: insulin degludec

Interventions

insulin degludec/liraglutideDRUG

IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.

IDegLira + metformin

insulin degludecDRUG

IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.

IDeg + metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 2 diabetes
HbA1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
Subjects on stable daily doses for at least 90 days prior to trial start of: Basal insulin (total daily basal insulin dose within the range of 20-40U in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and SU (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
BMI (Body Mass Index) more than or equal to 27 kg/m\^2

You may not qualify if:

Treatment with glucagon like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (DPP-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
Impaired liver function
Impaired renal function
Screening calcitonin equal to or above 50 ng/l
Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
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 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
Severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg)
Acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
History of chronic pancreatitis or idiopathic acute pancreatitis

Contact the study team to confirm eligibility.