MedDataX Logo

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

NCT ID: NCT02100475

Last Updated: 2017-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

NCT01952145

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

NCT01664247

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

NCT01388361

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

NCT03689374

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

NCT00614055

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insulin degludec/liraglutide + Metformin

Group Type EXPERIMENTAL

insulin degludec/liraglutide

Intervention Type DRUG

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.

Insulin degludec/liraglutide + Insulin Aspart + Metformin

Group Type ACTIVE_COMPARATOR

insulin degludec/liraglutide

Intervention Type DRUG

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.

insulin aspart

Intervention Type DRUG

Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin degludec/liraglutide

Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.

Intervention Type DRUG

insulin aspart

Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
* HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial

Exclusion Criteria

* Clinically significant diseases of the major organ systems
* Screening calcitonin above or equal to 50 ng/L
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Novo Nordisk Investigational Site

Gurnee, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Slidell, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Altoona, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Renton, Washington, United States

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Capital Federal, , Argentina

Site Status

Novo Nordisk Investigational Site

Corrientes, , Argentina

Site Status

Novo Nordisk Investigational Site

Salta, , Argentina

Site Status

Novo Nordisk Investigational Site

Zárate, , Argentina

Site Status

Novo Nordisk Investigational Site

Wollongong, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Herston, Queensland, Australia

Site Status

Novo Nordisk Investigational Site

Ipswich, Queensland, Australia

Site Status

Novo Nordisk Investigational Site

Robina, Queensland, Australia

Site Status

Novo Nordisk Investigational Site

East Ringwood, Victoria, Australia

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Ioannina, , Greece

Site Status

Novo Nordisk Investigational Site

Larissa, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Eger, , Hungary

Site Status

Novo Nordisk Investigational Site

Győr, , Hungary

Site Status

Novo Nordisk Investigational Site

Gyula, , Hungary

Site Status

Novo Nordisk Investigational Site

Miskolc, , Hungary

Site Status

Novo Nordisk Investigational Site

Pachuca, Hidalgo, Mexico

Site Status

Novo Nordisk Investigational Site

Cuernavaca, Morelos, Mexico

Site Status

Novo Nordisk Investigational Site

Mexico City, México, D.F., Mexico

Site Status

Novo Nordisk Investigational Site

Monterrey, , Mexico

Site Status

Novo Nordisk Investigational Site

Kazan', , Russia

Site Status

Novo Nordisk Investigational Site

Kirov, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Novosibirsk, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Tomsk, , Russia

Site Status

Novo Nordisk Investigational Site

Tomsk, , Russia

Site Status

Novo Nordisk Investigational Site

Volgograd, , Russia

Site Status

Novo Nordisk Investigational Site

Bardejov, , Slovakia

Site Status

Novo Nordisk Investigational Site

Dolný Kubín, , Slovakia

Site Status

Novo Nordisk Investigational Site

Košice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Levice, , Slovakia

Site Status

Novo Nordisk Investigational Site

Poprad, , Slovakia

Site Status

Novo Nordisk Investigational Site

Považská Bystrica, , Slovakia

Site Status

Novo Nordisk Investigational Site

Prievidza, , Slovakia

Site Status

Novo Nordisk Investigational Site

Trnava, , Slovakia

Site Status

Novo Nordisk Investigational Site

Veľký Meder, , Slovakia

Site Status

Novo Nordisk Investigational Site

Midrand, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Brits, North West, South Africa

Site Status

Novo Nordisk Investigational Site

Alberton, , South Africa

Site Status

Novo Nordisk Investigational Site

Almería, , Spain

Site Status

Novo Nordisk Investigational Site

Granada, , Spain

Site Status

Novo Nordisk Investigational Site

Palma de Mallorca, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Greece Hungary Mexico Russia Slovakia South Africa Spain

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-002878-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1145-0183

Identifier Type: OTHER

Identifier Source: secondary_id

NN9068-4119

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
NCT00613951 COMPLETED PHASE2
Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
NCT01045707 COMPLETED PHASE3
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00331851 COMPLETED PHASE3
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
NCT02648204 COMPLETED PHASE3
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
NCT00856986 COMPLETED PHASE3
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
NCT00318461 COMPLETED PHASE3
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes
NCT01392573 COMPLETED PHASE3
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
NCT02773368 COMPLETED PHASE3
A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
NCT02906917 COMPLETED PHASE3
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
NCT01618162 COMPLETED PHASE3
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
NCT01865305 COMPLETED PHASE1
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
NCT01868568 COMPLETED PHASE1
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
NCT00469092 COMPLETED PHASE4
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
NCT01336023 COMPLETED PHASE3
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
NCT02128932 COMPLETED PHASE3
A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
NCT04880850 COMPLETED PHASE3
A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
NCT02501161 COMPLETED PHASE3
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
NCT02420262 COMPLETED PHASE3
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms
NCT02298192 COMPLETED PHASE3
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
NCT00274274 COMPLETED PHASE4
Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes
NCT00972283 COMPLETED PHASE3
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00909480 COMPLETED PHASE4
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
NCT05813912 COMPLETED PHASE3
A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
NCT02205528 COMPLETED PHASE2
Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes
NCT03268005 COMPLETED PHASE3