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A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

NCT ID: NCT02298192

Last Updated: 2017-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-21

Study Completion Date

2015-12-23

Brief Summary

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This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

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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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Once weekly titration

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Twice weekly titration

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Interventions

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insulin degludec/liraglutide

For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus
* Male or female equal to or above 18 years of age
* HbA1c (glycosylated haemoglobin) 7.0 - 10.0% \[53 mmol/mol - 86 mmol/mol\] (both inclusive), confirmed by the central laboratory
* Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
* Body Mass Index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria

* Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
* Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
* Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
* Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
* Screening calcitonin above or equal to 50 ng/L
* Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
* History of pancreatitis (acute or chronic)
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

Hamilton, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Chandler, Arizona, United States

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Novo Nordisk Investigational Site

Glendale, Arizona, United States

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Novo Nordisk Investigational Site

Glendale, Arizona, United States

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Novo Nordisk Investigational Site

Mesa, Arizona, United States

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

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Novo Nordisk Investigational Site

Anaheim, California, United States

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Novo Nordisk Investigational Site

Palm Springs, California, United States

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Novo Nordisk Investigational Site

Walnut Creek, California, United States

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Novo Nordisk Investigational Site

Colorado Springs, Colorado, United States

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Novo Nordisk Investigational Site

Boynton Beach, Florida, United States

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Novo Nordisk Investigational Site

Clearwater, Florida, United States

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Novo Nordisk Investigational Site

Hallandale, Florida, United States

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Novo Nordisk Investigational Site

Miami, Florida, United States

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Novo Nordisk Investigational Site

Orlando, Florida, United States

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Novo Nordisk Investigational Site

Tampa, Florida, United States

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Novo Nordisk Investigational Site

Conyers, Georgia, United States

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Blackfoot, Idaho, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Novo Nordisk Investigational Site

Crestview Hills, Kentucky, United States

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Novo Nordisk Investigational Site

Troy, Michigan, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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West Seneca, New York, United States

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Novo Nordisk Investigational Site

Greensboro, North Carolina, United States

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Novo Nordisk Investigational Site

Norman, Oklahoma, United States

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Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

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Novo Nordisk Investigational Site

Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Humboldt, Tennessee, United States

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Kingsport, Tennessee, United States

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Houston, Texas, United States

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Katy, 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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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Novo Nordisk Investigational Site

Linz, , Austria

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Mödling, , Austria

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Saint Stefan, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Kozloduy, , Bulgaria

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Lukovit, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Novo Nordisk Investigational Site

Burnaby, British Columbia, Canada

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Novo Nordisk Investigational Site

Coquitlam, British Columbia, Canada

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Novo Nordisk Investigational Site

Surrey, British Columbia, Canada

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Novo Nordisk Investigational Site

Moncton, New Brunswick, Canada

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Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

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Novo Nordisk Investigational Site

Liverpool, Nova Scotia, Canada

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Novo Nordisk Investigational Site

London, Ontario, Canada

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Novo Nordisk Investigational Site

Waterloo, Ontario, Canada

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Novo Nordisk Investigational Site

Olomouc, Lazce, , Czechia

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Novo Nordisk Investigational Site

Pilsen, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Trutnov, , Czechia

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Szombathely, , Hungary

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Zalaegerszeg, , Hungary

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Barnaul, , Russia

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Barnaul, , Russia

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Novo Nordisk Investigational Site

Cheboksary, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Samara, , Russia

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Novo Nordisk Investigational Site

Belgrade, , Serbia

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Novo Nordisk Investigational Site

Bratislava, , Slovakia

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Novo Nordisk Investigational Site

Bratislava, , Slovakia

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Novo Nordisk Investigational Site

Bratislava, , Slovakia

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Novo Nordisk Investigational Site

Dunajská Streda, , Slovakia

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Novo Nordisk Investigational Site

Sabinov, , Slovakia

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Novo Nordisk Investigational Site

Vranov nad Topľou, , Slovakia

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Novo Nordisk Investigational Site

Žilina, , Slovakia

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Countries

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United States Austria Bulgaria Canada Czechia Hungary Russia Serbia Slovakia

References

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Safety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016

Reference Type RESULT

Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.

Reference Type RESULT
PMID: 28124817 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004625-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-6634

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4056

Identifier Type: -

Identifier Source: org_study_id

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