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The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

NCT ID: NCT01676116

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

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-29

Study Completion Date

2014-03-11

Brief Summary

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This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

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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

NONE

Study Groups

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Insulin degludec/liraglutide + OADs

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.

Liraglutide or exenatide + OADs

Group Type ACTIVE_COMPARATOR

liraglutide

Intervention Type DRUG

Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

exenatide

Intervention Type DRUG

Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Interventions

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insulin degludec/liraglutide

Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.

Intervention Type DRUG

liraglutide

Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Intervention Type DRUG

exenatide

Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus
* Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
* BMI (body mass index) equal to or below 40 kg/m\^2

Exclusion Criteria

* Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
* Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
* Screening calcitonin equal to or above 50 ng/l
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
* Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
* Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
* 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

Birmingham, Alabama, United States

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Goodyear, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Concord, California, United States

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Encino, California, United States

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Fair Oaks, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Lancaster, California, United States

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Lomita, California, United States

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Long Beach, California, United States

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Montclair, California, United States

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Northridge, California, United States

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San Mateo, California, United States

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San Ramon, California, United States

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Tarzana, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Springs, Florida, United States

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Orlando, Florida, United States

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Plant City, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Honolulu, Hawaii, United States

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Arlington Heights, Illinois, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Rockville, Maryland, United States

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Kalamazoo, Michigan, United States

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Troy, Michigan, United States

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Saint Charles, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Nashua, New Hampshire, United States

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Berlin, New Jersey, United States

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Flemington, New Jersey, United States

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Hamilton, New Jersey, 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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Mineola, New York, United States

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North Massapequa, New York, United States

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West Seneca, New York, United States

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Morehead City, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Altoona, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Myrtle Beach, South Carolina, United States

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Sumter, South Carolina, United States

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Chattanooga, Tennessee, United States

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Jellico, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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Tullahoma, 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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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Round Rock, 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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Schertz, Texas, United States

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Sugar Land, Texas, United States

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Orem, Utah, United States

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Salt Lake City, Utah, United States

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St. George, Utah, United States

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Richmond, Virginia, United States

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Coffs Harbour, New South Wales, Australia

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Merewether, New South Wales, Australia

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Keswick, South Australia, Australia

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Box Hill, Victoria, Australia

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Melbourne, Victoria, Australia

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Antibes, , France

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Boulogne-Billancourt, , France

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La Rochelle, , France

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Montigny-lès-Metz, , France

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Narbonne, , France

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Nîmes, , France

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Sète, , France

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Vénissieux, , France

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Budapest, , Hungary

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Debrecen, , Hungary

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Nyíregyhaza, , Hungary

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Székesfehérvár, , Hungary

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Lučenec, , Slovakia

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Nitra, , Slovakia

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Prešov, , Slovakia

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Countries

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United States Australia France Hungary Slovakia

References

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Linjawi S, Bode BW, Chaykin LB, Courreges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.

Reference Type RESULT
PMID: 27943107 (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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2012-000209-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1127-1321

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-3851

Identifier Type: -

Identifier Source: org_study_id

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