NCT01336023|CompletedPhase 3Results

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

DUAL™ I

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9068-3697U1111-1119-11742010-021560-15

Study Type

interventional

Target

1,663

Locations

20 countries

Sites

302

Timeline

RegisteredApr 2011

StartedMay 2011

CompletionNov 2012

Brief Summary

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,663

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started May 2011

Typical duration for phase_3 diabetes

Geographic Reach

20 countries

302 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

1.5 years study duration

First Submitted

Initial submission to the registry

April 13, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

May 23, 2011

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2012

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2012

Completed

4.5 years until next milestone

Results Posted

Study results publicly available

June 2, 2017

Completed

Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

April 13, 2011

Results QC Date

December 12, 2016

Last Update Submit

February 16, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
Values of mean change in HbA1c.
Week 0, week 26

Secondary Outcomes (4)

Mean Change From Baseline in Body Weight at Week 26
Week 0, Week 26
Number of Hypoglycaemic Episodes
Weeks 0-26
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
Week 0, Week 26
Mean Actual Daily Insulin Dose
Week 26

Study Arms (3)

IDeg

EXPERIMENTAL

Drug: insulin degludec

IDegLira

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Lira

EXPERIMENTAL

Drug: liraglutide

Interventions

insulin degludec/liraglutideDRUG

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

IDegLira

insulin degludecDRUG

Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.

IDeg

liraglutideDRUG

Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.

Lira

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 2 diabetes
HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening
Body Mass Index (BMI) maximum 40 kg/m\^2

You may not qualify if:

Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
Screening calcitonin at least 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 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
History of chronic pancreatitis or idiopathic acute pancreatitis

Contact the study team to confirm eligibility.