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The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

NCT ID: NCT01618162

Last Updated: 2017-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-29

Study Completion Date

2013-10-23

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 investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

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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Insulin degludec/liraglutide

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily.

Interventions

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insulin degludec/liraglutide

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Intervention Type DRUG

placebo

Injected subcutaneously (under the skin) once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 2 diabetes mellitus
* HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
* Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
* Body Mass Index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria

* Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
* Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
* Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
* 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 above or equal to 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 clinical 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 product
* 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

Anaheim, California, United States

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Novo Nordisk Investigational Site

Garden Grove, California, United States

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Novo Nordisk Investigational Site

La Jolla, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Mateo, California, United States

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Walnut Creek, California, United States

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Kissimmee, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Meridian, Idaho, United States

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Gurnee, Illinois, United States

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Crestview Hills, Kentucky, United States

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Rockville, Maryland, United States

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Troy, 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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Lodi, New Jersey, United States

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West Seneca, New York, United States

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Tabor City, North Carolina, United States

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Cincinnati, Ohio, United States

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Franklin, Ohio, United States

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Mason, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Pelzer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, 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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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Lukovit, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Burnaby, British Columbia, Canada

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Cambridge, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Mirabel, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Québec, , Canada

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Esslingen am Neckar, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Münster, , Germany

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Pohlheim, , Germany

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Rehlingen-Siersburg, , Germany

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Sulzbach-Rosenberg, , Germany

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Guwahati, Assam, India

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Guwahati, Assam, India

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Bangalore, Karnataka, India

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Belagavi, Karnataka, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Delhi, New Delhi, India

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Hyderabad, , India

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Manatí, , Puerto Rico

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Novo Nordisk Investigational Site

Izmir, , Turkey (Türkiye)

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Countries

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North Macedonia United States Bulgaria Canada Germany India Israel Puerto Rico Turkey (Türkiye)

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)

Rodbard HW, Bode BW, Harris SB, Rose L, Lehmann L, Jarlov H, Thurman J; Dual Action of Liraglutide and insulin degludec (DUAL) IV trial investigators. Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naive people with Type 2 diabetes: the DUAL IV trial. Diabet Med. 2017 Feb;34(2):189-196. doi: 10.1111/dme.13256. Epub 2016 Oct 7.

Reference Type RESULT
PMID: 27589252 (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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2012-000140-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1126-9776

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-3951

Identifier Type: -

Identifier Source: org_study_id