A Clinical Trial Comparing Efficacy & Safety of Insulin NCT02298192

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT02298192
Other study ID #	NN9068-4056
Secondary ID	2012-004625-25U1
Status	Completed
Phase	Phase 3
First received	November 19, 2014
Last updated	December 6, 2016
Start date	November 2014
Est. completion date	December 2015

Study information
Verified date	December 2016
Source	Novo Nordisk A/S
Contact	n/a
Is FDA regulated	No
Health authority	Austria: Agency for Health and Food SafetyBulgaria: Bulgarian Drug AgencyCanada: Public Health Agency of CanadaCzech Republic: State Institute for Drug ControlHungary: Ministry of Health, Social and Family AffairsRussia: Pharmacological Committee, Ministry of HealthSerbia: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlUnited States: Food and Drug Administration
Study type	Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status	Completed
Enrollment	420
Est. completion date	December 2015
Est. primary completion date	December 2015
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Linz
Austria	Novo Nordisk Investigational Site	Mödling
Austria	Novo Nordisk Investigational Site	St. Stefan
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Bulgaria	Novo Nordisk Investigational Site	Kozloduy
Bulgaria	Novo Nordisk Investigational Site	Lukovit
Bulgaria	Novo Nordisk Investigational Site	Ruse
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Varna
Canada	Novo Nordisk Investigational Site	Burnaby	British Columbia
Canada	Novo Nordisk Investigational Site	Coquitlam	British Columbia
Canada	Novo Nordisk Investigational Site	Halifax	Nova Scotia
Canada	Novo Nordisk Investigational Site	Liverpool	Nova Scotia
Canada	Novo Nordisk Investigational Site	London	Ontario
Canada	Novo Nordisk Investigational Site	Moncton	New Brunswick
Canada	Novo Nordisk Investigational Site	Surrey	British Columbia
Canada	Novo Nordisk Investigational Site	Waterloo	Ontario
Czech Republic	Novo Nordisk Investigational Site	Olomouc, Lazce
Czech Republic	Novo Nordisk Investigational Site	Plzen
Czech Republic	Novo Nordisk Investigational Site	Plzen
Czech Republic	Novo Nordisk Investigational Site	Praha 4
Czech Republic	Novo Nordisk Investigational Site	Trutnov
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Szombathely
Hungary	Novo Nordisk Investigational Site	Zalaegerszeg
Russian Federation	Novo Nordisk Investigational Site	Barnaul
Russian Federation	Novo Nordisk Investigational Site	Barnaul
Russian Federation	Novo Nordisk Investigational Site	Cheboksary
Russian Federation	Novo Nordisk Investigational Site	Saint-Petersburg
Russian Federation	Novo Nordisk Investigational Site	Samara
Russian Federation	Novo Nordisk Investigational Site	St. Petersburg
Serbia	Novo Nordisk Investigational Site	Belgrade
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Dunajska Streda
Slovakia	Novo Nordisk Investigational Site	Sabinov
Slovakia	Novo Nordisk Investigational Site	Vranov nad Toplou
Slovakia	Novo Nordisk Investigational Site	Zilina
United States	Novo Nordisk Investigational Site	Anaheim	California
United States	Novo Nordisk Investigational Site	Blackfoot	Idaho
United States	Novo Nordisk Investigational Site	Boynton Beach	Florida
United States	Novo Nordisk Investigational Site	Chandler	Arizona
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Clearwater	Florida
United States	Novo Nordisk Investigational Site	Colorado Springs	Colorado
United States	Novo Nordisk Investigational Site	Conyers	Georgia
United States	Novo Nordisk Investigational Site	Crestview Hills	Kentucky
United States	Novo Nordisk Investigational Site	Glendale	Arizona
United States	Novo Nordisk Investigational Site	Glendale	Arizona
United States	Novo Nordisk Investigational Site	Greensboro	North Carolina
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Hallandale Beach	Florida
United States	Novo Nordisk Investigational Site	Hamilton	Alabama
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Humboldt	Tennessee
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Katy	Texas
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Mesa	Arizona
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Nashua	New Hampshire
United States	Novo Nordisk Investigational Site	Newport News	Virginia
United States	Novo Nordisk Investigational Site	Norman	Oklahoma
United States	Novo Nordisk Investigational Site	Orlando	Florida
United States	Novo Nordisk Investigational Site	Palm Springs	California
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Phoenix	Arizona
United States	Novo Nordisk Investigational Site	Phoenix	Arizona
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Spartanburg	South Carolina
United States	Novo Nordisk Investigational Site	Tampa	Florida
United States	Novo Nordisk Investigational Site	Troy	Michigan
United States	Novo Nordisk Investigational Site	Tucson	Arizona
United States	Novo Nordisk Investigational Site	Walnut Creek	California
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, Austria, Bulgaria, Canada, Czech Republic, Hungary, Russian Federation, Serbia, Slovakia,

References & Publications (1)

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 - 7

Outcome
Type	Measure	Time frame	Safety issue
Primary	Change from baseline in HbA1c	Week 0, week 32	No
Secondary	HbA1c below 7.0%	Week 0, week 32	No
Secondary	HbA1c below or equal to 6.5%	Week 0, week 32	No
Secondary	Number of treatment emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes	Week 0-32	No

See also
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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
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Completed	`NCT05896319` - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2	N/A
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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
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	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
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	`NCT03620357` - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)	N/A
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) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

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