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

Diabetes Mellitus, Type 2 Clinical Trial

— DUAL™ I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336023
• Other study ID #: NN9068-3697
• Secondary ID: U1111-1119-11742
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2011
• Last updated: February 16, 2018
• Start date: May 23, 2011
• Est. completion date: November 22, 2012

Study information

• Verified date: February 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1663
• Est. completion date: November 22, 2012
• Est. primary completion date: May 24, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/liraglutide
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.
• insulin degludec
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.
• liraglutide
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.

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Broadmeadow	New South Wales
Australia	Novo Nordisk Investigational Site	Camperdown	New South Wales
Australia	Novo Nordisk Investigational Site	Coffs Harbour	New South Wales
Australia	Novo Nordisk Investigational Site	East Ringwood	Victoria
Australia	Novo Nordisk Investigational Site	Keswick	South Australia
Australia	Novo Nordisk Investigational Site	Meadowbrook	Queensland
Australia	Novo Nordisk Investigational Site	Melbourne	Victoria
Australia	Novo Nordisk Investigational Site	Penrith	New South Wales
Canada	Novo Nordisk Investigational Site	Brampton	Ontario
Canada	Novo Nordisk Investigational Site	Burlington	Ontario
Canada	Novo Nordisk Investigational Site	Chilliwack	British Columbia
Canada	Novo Nordisk Investigational Site	Cornwall	Ontario
Canada	Novo Nordisk Investigational Site	Drummondville	Quebec
Canada	Novo Nordisk Investigational Site	Edmonton	Alberta
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Laval	Quebec
Canada	Novo Nordisk Investigational Site	Mississauga	Ontario
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Canada	Novo Nordisk Investigational Site	Vancouver	British Columbia
Canada	Novo Nordisk Investigational Site	Winnipeg	Manitoba
Finland	Novo Nordisk Investigational Site	Hanko
Finland	Novo Nordisk Investigational Site	Helsinki
Finland	Novo Nordisk Investigational Site	Imatra
Finland	Novo Nordisk Investigational Site	Kokkola
Finland	Novo Nordisk Investigational Site	Oulu
Germany	Novo Nordisk Investigational Site	Bad Neuenahr-Ahrweiler
Germany	Novo Nordisk Investigational Site	Eisenach
Germany	Novo Nordisk Investigational Site	Esslingen
Germany	Novo Nordisk Investigational Site	Frankfurt
Germany	Novo Nordisk Investigational Site	Grevenbroich
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Herrenberg
Germany	Novo Nordisk Investigational Site	Hohenmölsen
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Oldenburg
Germany	Novo Nordisk Investigational Site	Pohlheim
Germany	Novo Nordisk Investigational Site	Rehburg-Loccum
Germany	Novo Nordisk Investigational Site	Rehlingen-Siersburg
Germany	Novo Nordisk Investigational Site	Stuttgart
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Eger
Hungary	Novo Nordisk Investigational Site	Gyula
Hungary	Novo Nordisk Investigational Site	Pécs
Hungary	Novo Nordisk Investigational Site	Szeged
India	Novo Nordisk Investigational Site	Ahmedabad	Gujarat
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bhubaneswar	Orissa
India	Novo Nordisk Investigational Site	Chennai	Tamil Nadu
India	Novo Nordisk Investigational Site	Chennai	Tamil Nadu
India	Novo Nordisk Investigational Site	Cochin	Kerala
India	Novo Nordisk Investigational Site	Gurgaon	Haryana
India	Novo Nordisk Investigational Site	Hyderabad
India	Novo Nordisk Investigational Site	Indore	Madhya Pradesh
India	Novo Nordisk Investigational Site	Jaipur	Rajasthan
India	Novo Nordisk Investigational Site	Jaipur	Rajasthan
India	Novo Nordisk Investigational Site	Kochi	Kerala
India	Novo Nordisk Investigational Site	Kolkata
India	Novo Nordisk Investigational Site	Kolkatta	West Bengal
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Patna
India	Novo Nordisk Investigational Site	Pune
India	Novo Nordisk Investigational Site	Pune	Maharashtra
India	Novo Nordisk Investigational Site	Thiruvanathapuram	Kerala
India	Novo Nordisk Investigational Site	Trichy	Tamil Nadu
India	Novo Nordisk Investigational Site	Trivandrum	Kerala
Ireland	Novo Nordisk Investigational Site	Dublin
Ireland	Novo Nordisk Investigational Site	Galway
Italy	Novo Nordisk Investigational Site	Cosenza
Italy	Novo Nordisk Investigational Site	Forlì
Italy	Novo Nordisk Investigational Site	Monserrato, Cagliari
Italy	Novo Nordisk Investigational Site	Novara
Italy	Novo Nordisk Investigational Site	Olbia
Italy	Novo Nordisk Investigational Site	Palermo
Italy	Novo Nordisk Investigational Site	Siena
Italy	Novo Nordisk Investigational Site	Torino
Malaysia	Novo Nordisk Investigational Site	Cheras
Malaysia	Novo Nordisk Investigational Site	Kota Bharu, Kelantan
Malaysia	Novo Nordisk Investigational Site	Penang
Malaysia	Novo Nordisk Investigational Site	Pulau Pinang
Malaysia	Novo Nordisk Investigational Site	Putrajaya
Malaysia	Novo Nordisk Investigational Site	Seremban
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Monterrey	Nuevo León
Puerto Rico	Novo Nordisk Investigational Site	San Juan
Russian Federation	Novo Nordisk Investigational Site	Kursk
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Penza
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Saratov
Russian Federation	Novo Nordisk Investigational Site	Stavropol
Russian Federation	Novo Nordisk Investigational Site	Voronezh
Russian Federation	Novo Nordisk Investigational Site	Vsevolozhsk
Singapore	Novo Nordisk Investigational Site	Singapore
Singapore	Novo Nordisk Investigational Site	Singapore
Singapore	Novo Nordisk Investigational Site	Singapore
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Lucenec
Slovakia	Novo Nordisk Investigational Site	Moldava nad Bodvou
Slovakia	Novo Nordisk Investigational Site	Nove Zamky
South Africa	Novo Nordisk Investigational Site	Bloemfontein	Free State
South Africa	Novo Nordisk Investigational Site	Brits	North West
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape
South Africa	Novo Nordisk Investigational Site	Umkomaas	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Vaderbijlpark	Gauteng
Spain	Novo Nordisk Investigational Site	Almería
Spain	Novo Nordisk Investigational Site	Granada
Spain	Novo Nordisk Investigational Site	La Coruña
Spain	Novo Nordisk Investigational Site	Partida De Bacarot
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valencia
Spain	Novo Nordisk Investigational Site	Valladolid
Taiwan	Novo Nordisk Investigational Site	Taichung City
Taiwan	Novo Nordisk Investigational Site	Tainan city
Taiwan	Novo Nordisk Investigational Site	Taipei
Taiwan	Novo Nordisk Investigational Site	Taoyuan
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkoknoi, Bangkok
Thailand	Novo Nordisk Investigational Site	Chiang Mai
United Kingdom	Novo Nordisk Investigational Site	Belfast
United Kingdom	Novo Nordisk Investigational Site	Bury St Edmunds
United Kingdom	Novo Nordisk Investigational Site	Carmarthen
United Kingdom	Novo Nordisk Investigational Site	Dundee
United Kingdom	Novo Nordisk Investigational Site	Edgbaston, Birmingham
United Kingdom	Novo Nordisk Investigational Site	Fife
United Kingdom	Novo Nordisk Investigational Site	Glasgow
United Kingdom	Novo Nordisk Investigational Site	Gloucester
United Kingdom	Novo Nordisk Investigational Site	Headington
United Kingdom	Novo Nordisk Investigational Site	Lancaster
United Kingdom	Novo Nordisk Investigational Site	Letchworth
United Kingdom	Novo Nordisk Investigational Site	Llantrisant
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	St Helens
United Kingdom	Novo Nordisk Investigational Site	Stevenage
United Kingdom	Novo Nordisk Investigational Site	Weston Super Mare
United Kingdom	Novo Nordisk Investigational Site	Wrexham
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Asheboro	North Carolina
United States	Novo Nordisk Investigational Site	Asheville	North Carolina
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Avon	Illinois
United States	Novo Nordisk Investigational Site	Beaver	Pennsylvania
United States	Novo Nordisk Investigational Site	Bermuda Dunes	California
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Bridgeville	Pennsylvania
United States	Novo Nordisk Investigational Site	Bronx	New York
United States	Novo Nordisk Investigational Site	Buckley	Michigan
United States	Novo Nordisk Investigational Site	Burke	Virginia
United States	Novo Nordisk Investigational Site	Burlington	North Carolina
United States	Novo Nordisk Investigational Site	Canton	Ohio
United States	Novo Nordisk Investigational Site	Chapel Hill	North Carolina
United States	Novo Nordisk Investigational Site	Charlotte	North Carolina
United States	Novo Nordisk Investigational Site	Chattanooga	Tennessee
United States	Novo Nordisk Investigational Site	Chattanooga	Tennessee
United States	Novo Nordisk Investigational Site	Chesterfield	Missouri
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Clearwater	Florida
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Colorado Springs	Colorado
United States	Novo Nordisk Investigational Site	Columbia	South Carolina
United States	Novo Nordisk Investigational Site	Columbus	Ohio
United States	Novo Nordisk Investigational Site	Columbus	Georgia
United States	Novo Nordisk Investigational Site	Concord	California
United States	Novo Nordisk Investigational Site	Conyers	Georgia
United States	Novo Nordisk Investigational Site	Crestview Hills	Kentucky
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Decatur	Georgia
United States	Novo Nordisk Investigational Site	Delray Beach	Florida
United States	Novo Nordisk Investigational Site	Denver	Colorado
United States	Novo Nordisk Investigational Site	DeSoto	Texas
United States	Novo Nordisk Investigational Site	East Providence	Rhode Island
United States	Novo Nordisk Investigational Site	Encino	California
United States	Novo Nordisk Investigational Site	Fair Oaks	California
United States	Novo Nordisk Investigational Site	Fishers	Indiana
United States	Novo Nordisk Investigational Site	Flemington	New Jersey
United States	Novo Nordisk Investigational Site	Fort Lauderdale	Florida
United States	Novo Nordisk Investigational Site	Fort Worth	Texas
United States	Novo Nordisk Investigational Site	Franklin	Ohio
United States	Novo Nordisk Investigational Site	Franklin	Indiana
United States	Novo Nordisk Investigational Site	Fresno	California
United States	Novo Nordisk Investigational Site	Golden	Colorado
United States	Novo Nordisk Investigational Site	Greenbrae	California
United States	Novo Nordisk Investigational Site	Greensboro	North Carolina
United States	Novo Nordisk Investigational Site	Greenville	North Carolina
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Gurnee	Illinois
United States	Novo Nordisk Investigational Site	Henderson	Nevada
United States	Novo Nordisk Investigational Site	Hialeah	Florida
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Hyattsville	Maryland
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Irving	Texas
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Kansas City	Missouri
United States	Novo Nordisk Investigational Site	Kettering	Ohio
United States	Novo Nordisk Investigational Site	Killeen	Texas
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Kissimmee	Florida
United States	Novo Nordisk Investigational Site	La Jolla	California
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Lawrenceville	Georgia
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Long Beach	California
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Lubbock	Texas
United States	Novo Nordisk Investigational Site	Manassas	Virginia
United States	Novo Nordisk Investigational Site	Mason	Ohio
United States	Novo Nordisk Investigational Site	Maumee	Ohio
United States	Novo Nordisk Investigational Site	Melbourne	Florida
United States	Novo Nordisk Investigational Site	Meridian	Idaho
United States	Novo Nordisk Investigational Site	Metairie	Louisiana
United States	Novo Nordisk Investigational Site	Metairie	Louisiana
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Michigan City	Indiana
United States	Novo Nordisk Investigational Site	Milwaukee	Wisconsin
United States	Novo Nordisk Investigational Site	Montclair	California
United States	Novo Nordisk Investigational Site	Monterey	California
United States	Novo Nordisk Investigational Site	Morehead City	North Carolina
United States	Novo Nordisk Investigational Site	Muncie	Indiana
United States	Novo Nordisk Investigational Site	Nampa	Idaho
United States	Novo Nordisk Investigational Site	Nashua	New Hampshire
United States	Novo Nordisk Investigational Site	Newark	Delaware
United States	Novo Nordisk Investigational Site	Newport News	Virginia
United States	Novo Nordisk Investigational Site	Norristown	Pennsylvania
United States	Novo Nordisk Investigational Site	North East	Maryland
United States	Novo Nordisk Investigational Site	Northport	New York
United States	Novo Nordisk Investigational Site	O'Fallon	Illinois
United States	Novo Nordisk Investigational Site	Ogden	Utah
United States	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma
United States	Novo Nordisk Investigational Site	Orange	California
United States	Novo Nordisk Investigational Site	Orlando	Florida
United States	Novo Nordisk Investigational Site	Pelzer	South Carolina
United States	Novo Nordisk Investigational Site	Pembroke Pines	Florida
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Poway	California
United States	Novo Nordisk Investigational Site	Rockville	Maryland
United States	Novo Nordisk Investigational Site	Roswell	Georgia
United States	Novo Nordisk Investigational Site	Saint Charles	Missouri
United States	Novo Nordisk Investigational Site	Saint George	Utah
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	San Diego	California
United States	Novo Nordisk Investigational Site	San Mateo	California
United States	Novo Nordisk Investigational Site	Santa Barbara	California
United States	Novo Nordisk Investigational Site	Shelby	North Carolina
United States	Novo Nordisk Investigational Site	Simpsonville	South Carolina
United States	Novo Nordisk Investigational Site	Southfield	Michigan
United States	Novo Nordisk Investigational Site	Southfield	Michigan
United States	Novo Nordisk Investigational Site	Spartanburg	South Carolina
United States	Novo Nordisk Investigational Site	Spokane	Washington
United States	Novo Nordisk Investigational Site	Statesville	North Carolina
United States	Novo Nordisk Investigational Site	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Syracuse	New York
United States	Novo Nordisk Investigational Site	Tampa	Florida
United States	Novo Nordisk Investigational Site	Taylors	South Carolina
United States	Novo Nordisk Investigational Site	Toms River	New Jersey
United States	Novo Nordisk Investigational Site	Toms River	New Jersey
United States	Novo Nordisk Investigational Site	Troy	Michigan
United States	Novo Nordisk Investigational Site	Tustin	California
United States	Novo Nordisk Investigational Site	Valencia	California
United States	Novo Nordisk Investigational Site	Virginia Beach	Virginia
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	West Seneca	New York
United States	Novo Nordisk Investigational Site	Winston-Salem	North Carolina
United States	Novo Nordisk Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Finland,  Germany,  Hungary,  India,  Ireland,  Italy,  Malaysia,  Mexico,  Puerto Rico,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

References & Publications (8)

Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB; NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given a — View Citation

Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M, Reiter PD, Buse JB. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial — View Citation

Holst JJ, Buse JB, Rodbard HW, Linjawi S, Woo VC, Boesgaard TW, Kvist K, Gough SC. IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test. J Diabetes Sci Technol. 20 — View Citation

Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 1 — View Citation

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. — View Citation

King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsbøll 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 — View Citation

Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. — View Citation

Vilsbøll 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.	Values of mean change in HbA1c.	Week 0, week 26
Secondary	Mean Change From Baseline in Body Weight at Week 26	Values of mean change in body weight.	Week 0, Week 26
Secondary	Number of Hypoglycaemic Episodes	Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.	Weeks 0-26
Secondary	Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test	Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.	Week 0, Week 26
Secondary	Mean Actual Daily Insulin Dose	Mean of the actual doses recorded at visit 28 (Week 26).	Week 26

External Links

•   Clinical Trials at Novo Nordisk