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

NCT ID: NCT01392573

Last Updated: 2019-01-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-28

Study Completion Date

2012-10-04

Brief Summary

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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.

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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

DOUBLE

Participants Investigators

Study Groups

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IDegLira + metformin

IDegLira was injected subcutaneously once daily for 26 weeks.

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

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.

IDeg + metformin

IDeg was injected subcutaneously once daily for 26 weeks.

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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.

Interventions

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insulin degludec/liraglutide

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.

Intervention Type DRUG

insulin degludec

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

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

Huntsville, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Vestavia Hills, Alabama, United States

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Novo Nordisk Investigational Site

Anaheim, California, United States

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Los Angeles, California, United States

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Tustin, California, United States

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Ventura, California, United States

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Colorado Springs, Colorado, United States

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Waterbury, Connecticut, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Roswell, Georgia, United States

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Arlington Heights, Illinois, United States

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Avon, Illinois, United States

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Chicago, Illinois, United States

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Crystal Lake, Illinois, United States

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Gurnee, Illinois, United States

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Greenfield, Indiana, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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New Albany, Indiana, United States

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Lexington, Kentucky, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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Slidell, Louisiana, United States

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Rockville, Maryland, United States

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Methuen, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Waltham, Massachusetts, United States

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Southfield, Michigan, United States

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Chesterfield, Missouri, United States

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Saint Charles, Missouri, United States

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Nashua, New Hampshire, United States

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Lawrenceville, New Jersey, United States

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Toms River, New Jersey, United States

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Albany, New York, United States

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Smithtown, New York, United States

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Asheboro, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Statesville, North Carolina, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Hurst, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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Burgas, , Bulgaria

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Haskovo, , Bulgaria

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Lukovit, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Århus C, , Denmark

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Gentofte Municipality, , Denmark

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Hellerup, , Denmark

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Budapest, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Szombathely, , Hungary

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Chennai, Tamil Nadu, India

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Kolkata, West Bengal, India

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Dhantoli, Nagpur, , India

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Koper, , Slovenia

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Ljubljana, , Slovenia

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Novo Mesto, , Slovenia

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Basel, , Switzerland

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Bern, , Switzerland

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Interlaken-Unterseen, , Switzerland

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Lausanne, , Switzerland

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Lucerne, , Switzerland

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Sankt Gallen, , Switzerland

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Countries

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United States Bulgaria Denmark Hungary India Slovenia Switzerland

References

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Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.

Reference Type BACKGROUND
PMID: 28332144 (View on PubMed)

Ericsson A, Lundqvist A. Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden. Appl Health Econ Health Policy. 2017 Apr;15(2):237-248. doi: 10.1007/s40258-016-0301-y.

Reference Type BACKGROUND
PMID: 28063135 (View on PubMed)

Buse JB, Vilsboll T, Thurman J, Blevins TC, Langbakke IH, Bottcher SG, Rodbard HW; NN9068-3912 (DUAL-II) Trial Investigators. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014 Nov;37(11):2926-33. doi: 10.2337/dc14-0785. Epub 2014 Aug 11.

Reference Type RESULT
PMID: 25114296 (View on PubMed)

Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.

Reference Type RESULT
PMID: 26894800 (View on PubMed)

King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.

Reference Type RESULT
PMID: 28282219 (View on PubMed)

Lingvay I, Handelsman Y, Linjawi S, Vilsboll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

Reference Type RESULT
PMID: 30383495 (View on PubMed)

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-002336-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-4897

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-3912

Identifier Type: -

Identifier Source: org_study_id

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