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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002878-47 | EudraCT Number | ||
| U1111-1145-0183 | Other Identifier | WHO |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec/liraglutide + Metformin | Experimental |
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| Insulin degludec/liraglutide + Insulin Aspart + Metformin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin degludec/liraglutide | Drug | Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of treatment. | Week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | Week 0, week 26 |
| Number of Treatment-emergent Confirmed Hypoglycaemic Episodes | Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Fresno | California | 93720 | United States | ||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects with type 2 diabetes mellitus who were inadequately controlled (HbA1c level ≥ 7% [53 mmol/mol]) on treatment with IDegLira and metformin after 26 weeks of treatment in the NN9068-3952 trial were screened. Eligible subjects were randomised in a 1:1 manner to one of the two parallel treatment groups (IDegLira or IDegLira + IAsp).
The trial was conducted at 19 sites in 8 countries as follows: Argentina: 2 sites; Greece: 2 sites, Hungary: 1 site; Russian Federation: 5 sites; Slovakia: 4 sites, South Africa: 1 site; Spain: 1 site, United States: 3 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDegLira | Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin aspart | Drug | Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily. |
|
| Week 0 - 26 |
| Fort Lauderdale |
| Florida |
| 33316-2521 |
| United States |
| Novo Nordisk Investigational Site | Gurnee | Illinois | 60031 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | United States |
| Novo Nordisk Investigational Site | Slidell | Louisiana | 70461-4231 | United States |
| Novo Nordisk Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Novo Nordisk Investigational Site | Renton | Washington | 98057 | United States |
| Novo Nordisk Investigational Site | Buenos Aires | B1704ETD | Argentina |
| Novo Nordisk Investigational Site | Capital Federal | C1056ABJ | Argentina |
| Novo Nordisk Investigational Site | Corrientes | 3400 | Argentina |
| Novo Nordisk Investigational Site | Salta | 4400 | Argentina |
| Novo Nordisk Investigational Site | Zárate | B2800DGH | Argentina |
| Novo Nordisk Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| Novo Nordisk Investigational Site | Herston | Queensland | 4029 | Australia |
| Novo Nordisk Investigational Site | Ipswich | Queensland | 4305 | Australia |
| Novo Nordisk Investigational Site | Robina | Queensland | 4226 | Australia |
| Novo Nordisk Investigational Site | East Ringwood | Victoria | 3135 | Australia |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Ioannina | 45500 | Greece |
| Novo Nordisk Investigational Site | Larissa | GR-41110 | Greece |
| Novo Nordisk Investigational Site | Thessaloniki | GR-54642 | Greece |
| Novo Nordisk Investigational Site | Thessaloniki | GR-57001 | Greece |
| Novo Nordisk Investigational Site | Eger | 3300 | Hungary |
| Novo Nordisk Investigational Site | Győr | 9024 | Hungary |
| Novo Nordisk Investigational Site | Gyula | 5700 | Hungary |
| Novo Nordisk Investigational Site | Miskolc | 3526 | Hungary |
| Novo Nordisk Investigational Site | Pachuca | Hidalgo | 42084 | Mexico |
| Novo Nordisk Investigational Site | Cuernavaca | Morelos | 62250 | Mexico |
| Novo Nordisk Investigational Site | Mexico City | México, D.F. | 03300 | Mexico |
| Novo Nordisk Investigational Site | Monterrey | 64460 | Mexico |
| Novo Nordisk Investigational Site | Kazan' | 420073 | Russia |
| Novo Nordisk Investigational Site | Kirov | 610014 | Russia |
| Novo Nordisk Investigational Site | Moscow | 117036 | Russia |
| Novo Nordisk Investigational Site | Moscow | 123448 | Russia |
| Novo Nordisk Investigational Site | Novosibirsk | 630117 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194354 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194358 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 199034 | Russia |
| Novo Nordisk Investigational Site | Tomsk | 634034 | Russia |
| Novo Nordisk Investigational Site | Tomsk | 634041 | Russia |
| Novo Nordisk Investigational Site | Volgograd | 400131 | Russia |
| Novo Nordisk Investigational Site | Bardejov | 08501 | Slovakia |
| Novo Nordisk Investigational Site | Dolný Kubín | 02601 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 040 11 | Slovakia |
| Novo Nordisk Investigational Site | Levice | 93401 | Slovakia |
| Novo Nordisk Investigational Site | Poprad | 05801 | Slovakia |
| Novo Nordisk Investigational Site | Považská Bystrica | 01701 | Slovakia |
| Novo Nordisk Investigational Site | Prievidza | 97101 | Slovakia |
| Novo Nordisk Investigational Site | Trnava | 91701 | Slovakia |
| Novo Nordisk Investigational Site | Veľký Meder | 93201 | Slovakia |
| Novo Nordisk Investigational Site | Midrand | Gauteng | 1685 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4450 | South Africa |
| Novo Nordisk Investigational Site | Brits | North West | 0250 | South Africa |
| Novo Nordisk Investigational Site | Alberton | 1449 | South Africa |
| Novo Nordisk Investigational Site | Almería | 04001 | Spain |
| Novo Nordisk Investigational Site | Granada | 18012 | Spain |
| Novo Nordisk Investigational Site | Palma de Mallorca | 07014 | Spain |
| Novo Nordisk Investigational Site | Seville | 41003 | Spain |
| Novo Nordisk Investigational Site | Seville | 41010 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| FG001 | IDegLira + IAsp | IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). |
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| NOT COMPLETED |
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Baseline characteristics were presented for full analysis set (FAS = 31 subjects).
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| ID | Title | Description |
|---|---|---|
| BG000 | IDegLira | Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). |
| BG001 | IDegLira + IAsp | IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| HbA1c | Mean | Standard Deviation | Percentage of glycosylated haemoglobin |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of treatment. | Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method. | Posted | Mean | Standard Deviation | Percentage of glycosylated haemoglobin | Week 0, week 26 |
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| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of treatment. | FAS included all randomised subject (31 subjects). Missing data were imputed using the LOCF method. | Posted | Mean | Standard Deviation | Kilograms | Week 0, week 26 |
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| Secondary | Number of Treatment-emergent Confirmed Hypoglycaemic Episodes | Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL). | Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (31 subjects). Confirmed hypoglycaemic episodes were reported by 2 subjects in IDegLira arm and 2 subjects in IDegLira + IAsp arm. | Posted | Number | Number of episodes | Week 0 - 26 |
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From first trial-related activity (week 0) after the subject had signed the informed consent until the end of the post-treatment follow-up period (week 27).
SAS included all subjects receiving at least one dose of the investigational product or comparator, (SAS = 31 subjects).
A treatment-emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDegLira | Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). | 1 | 16 | 11 | 16 | ||
| EG001 | IDegLira + IAsp | IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose). | 2 | 15 | 3 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
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| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Coronary revascularisation | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Blood calcitonin increased | Investigations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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Due to the small number of subjects in this trial, the data should be interpreted with caution.
At the end of trial, one or more scientific publications may be prepared collaboratively by the investigators and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| Units | Counts |
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| Participants |
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