A Clinical Trial Comparing Efficacy & Safety of Insulin NCT02420262

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT02420262
Other study ID #	NN9068-4185
Secondary ID	2014-003621-18U1
Status	Completed
Phase	Phase 3
First received	April 8, 2015
Last updated	March 1, 2018
Start date	July 26, 2015
Est. completion date	October 5, 2016

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

Clinical Trial Summary

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Recruitment information / eligibility
Status	Completed
Enrollment	506
Est. completion date	October 5, 2016
Est. primary completion date	October 5, 2016
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening - HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening - Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive - Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening - Body mass index (BMI) below or equal to 40 kg/m^2 Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening - Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids) - Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal - Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Screening calcitonin at least 50 ng/L - History of pancreatitis (acute or chronic) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
• insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
• insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.

Locations
Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Caba
Argentina	Novo Nordisk Investigational Site	Capital Federal
Argentina	Novo Nordisk Investigational Site	Córdoba
Argentina	Novo Nordisk Investigational Site	Salta
Czechia	Novo Nordisk Investigational Site	Brno
Czechia	Novo Nordisk Investigational Site	Hradec Králové
Czechia	Novo Nordisk Investigational Site	Olomouc
Czechia	Novo Nordisk Investigational Site	Olomouc, Lazce
Czechia	Novo Nordisk Investigational Site	Pardubice
Czechia	Novo Nordisk Investigational Site	Prostejov
France	Novo Nordisk Investigational Site	Angers
France	Novo Nordisk Investigational Site	Bourgoin-jallieu
France	Novo Nordisk Investigational Site	Brest
France	Novo Nordisk Investigational Site	LA ROCHELLE cedex
France	Novo Nordisk Investigational Site	Le Coudray
France	Novo Nordisk Investigational Site	Le Creusot
France	Novo Nordisk Investigational Site	Marseille
France	Novo Nordisk Investigational Site	MARSEILLE cedex 08
France	Novo Nordisk Investigational Site	Saint Herblain
France	Novo Nordisk Investigational Site	Saint Priest en Jarez
France	Novo Nordisk Investigational Site	Strasbourg
France	Novo Nordisk Investigational Site	Venissieux
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Chalkida, Evia
Greece	Novo Nordisk Investigational Site	Ioannina
Greece	Novo Nordisk Investigational Site	Larissa
Greece	Novo Nordisk Investigational Site	Thessaloniki
Greece	Novo Nordisk Investigational Site	Thessaloniki
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Gyula
Hungary	Novo Nordisk Investigational Site	Szeged
Hungary	Novo Nordisk Investigational Site	Szombathely
Hungary	Novo Nordisk Investigational Site	Tatabánya
Israel	Novo Nordisk Investigational Site	Haifa
Israel	Novo Nordisk Investigational Site	Holon
Israel	Novo Nordisk Investigational Site	Jerusalem
Israel	Novo Nordisk Investigational Site	Kfar Saba
Israel	Novo Nordisk Investigational Site	Nahariya
Israel	Novo Nordisk Investigational Site	Rehovot
Mexico	Novo Nordisk Investigational Site	Aguascalientes
Mexico	Novo Nordisk Investigational Site	Durango
Mexico	Novo Nordisk Investigational Site	Guadalajara	Jalisco
Mexico	Novo Nordisk Investigational Site	Mexico City	México, D.F.
Russian Federation	Novo Nordisk Investigational Site	Kazan
Russian Federation	Novo Nordisk Investigational Site	Moscow
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	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Volgograd
Slovakia	Novo Nordisk Investigational Site	Bardejov
Slovakia	Novo Nordisk Investigational Site	Dolny Kubin
Slovakia	Novo Nordisk Investigational Site	Malacky
Slovakia	Novo Nordisk Investigational Site	Poprad
Slovakia	Novo Nordisk Investigational Site	Roznava
Spain	Novo Nordisk Investigational Site	Almería
Spain	Novo Nordisk Investigational Site	Fuenlabrada - Madrid
Spain	Novo Nordisk Investigational Site	Pozuelo de Alarcon
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Sevilla
Spain	Novo Nordisk Investigational Site	Valencia
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Antalya
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Albuquerque	New Mexico
United States	Novo Nordisk Investigational Site	Altoona	Pennsylvania
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Bermuda Dunes	California
United States	Novo Nordisk Investigational Site	Billings	Montana
United States	Novo Nordisk Investigational Site	Blackfoot	Idaho
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Cincinnati	Ohio
United States	Novo Nordisk Investigational Site	Columbus	Ohio
United States	Novo Nordisk Investigational Site	Dayton	Ohio
United States	Novo Nordisk Investigational Site	Fresno	California
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Jackson Heights	New York
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Lancaster	California
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Lincoln	California
United States	Novo Nordisk Investigational Site	Lomita	California
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Mason	Ohio
United States	Novo Nordisk Investigational Site	Metairie	Louisiana
United States	Novo Nordisk Investigational Site	Midlothian	Virginia
United States	Novo Nordisk Investigational Site	Montclair	California
United States	Novo Nordisk Investigational Site	Murrells Inlet	South Carolina
United States	Novo Nordisk Investigational Site	Natchitoches	Louisiana
United States	Novo Nordisk Investigational Site	New Windsor	New York
United States	Novo Nordisk Investigational Site	Northridge	California
United States	Novo Nordisk Investigational Site	Palm Harbor	Florida
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Plantation	Florida
United States	Novo Nordisk Investigational Site	Rockville	Maryland
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Mateo	California
United States	Novo Nordisk Investigational Site	Shelby	North Carolina
United States	Novo Nordisk Investigational Site	Shreveport	Louisiana
United States	Novo Nordisk Investigational Site	Skokie	Illinois
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	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Tuscumbia	Alabama
United States	Novo Nordisk Investigational Site	Ventura	California
United States	Novo Nordisk Investigational Site	Waltham	Massachusetts
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	West Seneca	New York

Sponsors *(1)*
Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States, Argentina, Czechia, France, Greece, Hungary, Israel, Mexico, Russian Federation, Slovakia, Spain, Turkey,

References & Publications (1)

Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Grøn R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin; DUAL VII Rand — View Citation

Outcome
Type	Measure	Description	Time frame
Primary	Change in HbA1c (Glycosylated Haemoglobin)	Change in HbA1c values after 26 weeks of treatment.	Week 0, Week 26
Secondary	Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.	Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.	Weeks 0-26
Secondary	Change in Body Weight	Change in body weight after 26 weeks of treatment.	Week 0, Week 26
Secondary	Responder for HbA1c Below 7.0%	Number of subjects with HbA1c below 7% after 26 weeks of treatment.	After 26 weeks of treatment
Secondary	Responder for HbA1c Below or Equal to 6.5 %	Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.	After 26 weeks of treatment

See also
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Active, not recruiting	`NCT05661799` - Persistence of Physical Activity in People With Type 2 Diabetes Over Time.	N/A
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Completed	`NCT02836704` - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)	Phase 4
Completed	`NCT01819129` - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes	Phase 3
Completed	`NCT04562714` - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy	N/A
Completed	`NCT02009488` - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)	Phase 1
Completed	`NCT05896319` - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2	N/A
Recruiting	`NCT05598203` - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes	N/A
Completed	`NCT05046873` - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People	Phase 1
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT04090242` - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes	N/A
Completed	`NCT03620357` - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)	N/A
Completed	`NCT03604224` - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed	`NCT03620890` - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy	Phase 4
Withdrawn	`NCT05473286` - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting	`NCT05029804` - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes	N/A
Completed	`NCT04531631` - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes	Phase 2

External Links

Clinical Trials at Novo Nordisk

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Countries where clinical trial is conducted

References & Publications (1)

Outcome

External Links