DiabetesPhase 3NCT01880736

A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 40 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 458 participants
Where: 40 sitesJapan
Study dates: Jun 2013to Apr 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
Body mass index (BMI) equal to or below 35 kg/m^2

Who cannot join

Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

Japan40 sites

Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0027
Novo Nordisk Investigational Site
Fukui-shi, Fukui, 918-8503
Novo Nordisk Investigational Site
Fukuoka, 812 0025
Novo Nordisk Investigational Site
Gifu-shi, Gifu, 501-1194
Novo Nordisk Investigational Site
Izumisano, 598 0048
Novo Nordisk Investigational Site
Kagoshima-shi, Kagoshima, 890-8520
Novo Nordisk Investigational Site
Kamakura-shi, 247 0056
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, 125 0054
Novo Nordisk Investigational Site
Kawasaki-shi, Kanagawa, 216-8511
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, 800 0252
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, 807-8555
Novo Nordisk Investigational Site
Kitakyusyu-shi, Fukuoka, 800-0222
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, 963 8851
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, 862 0976
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, 310-0845
Novo Nordisk Investigational Site
Miyazaki, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, 311 0113
Novo Nordisk Investigational Site
Niigata-shi, Niigata, 951-8520
Novo Nordisk Investigational Site
Nishinomiya-shi, Hyogo, 663-8501
Novo Nordisk Investigational Site
Ōita, 870 0039
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, 831 0016
Novo Nordisk Investigational Site
Osaka-shi, Osaka, 532 0003
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, 323 0022
Novo Nordisk Investigational Site
Sakaide-shi, Kagawa, 762-0031
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060-0001
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 062 0007
Novo Nordisk Investigational Site
Sendai, 980 0021
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329 0433
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, 569 1096
Novo Nordisk Investigational Site
Tokyo, 103-0028
Novo Nordisk Investigational Site
Tokyo, 113-8655
Novo Nordisk Investigational Site
Tokyo, 123-0845
Novo Nordisk Investigational Site
Tokyo, 143-8541
Novo Nordisk Investigational Site
Tokyo, 144-0051
Novo Nordisk Investigational Site
Tokyo, 162-8655
Novo Nordisk Investigational Site
Yokkaichi-shi, Mie, 510-0829

Other trials in Japan

About this study

Official title: A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludecDrug
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.
insulin degludecDrug
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.
insulin degludecDrug
Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Study groups in NCT01880736
Study group	Role	What they receive
IDeg OD Flexible Dose	Experimental	Not described Receives: Drug: insulin degludec
IDeg OD Fixed Dose	Experimental	Not described Receives: Drug: insulin degludec
IDeg OD Simple	Experimental	Not described Receives: Drug: insulin degludec
IDeg OD Stepwise	Experimental	Not described Receives: Drug: insulin degludec

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
Measured: Week 0, week 26

Secondary outcomes (8)

Change From Baseline in Fasting Plasma Glucose (FPG)
Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Measured: Week 0, week 26
Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Measured: After 26 weeks of treatment
Incidence of Treatment Emergent Adverse Events (TEAEs)
The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).
Measured: Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))
The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).
Measured: Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).
Measured: Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.
Measured: From Week 16 to end of trial (week 27)
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period
The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: From week 16 to end of trial (week 27)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Apr 2014

First posted19 Jun 2013 (estimated)
Study startJun 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 458 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01880736
Sponsor's protocol ID: NN1250-4060
Other IDs: U1111-1137-0953, JapicCTI- 132164
Status last verified: Dec 2016
First submitted: 14 Jun 2013
Last updated: 10 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial. Diabetol Int. 2016 Sep 2;8(1):87-94. doi: 10.1007/s13340-016-0284-9. eCollection 2017 Mar.
PubMed 30603311
Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial. J Diabetes Investig. 2016 Sep;7(5):711-7. doi: 10.1111/jdi.12502. Epub 2016 Apr 1.
PubMed 27182031

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01880736
Acronym / sponsor ID: NN1250-4060
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 458 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 19 Jun 2013 (estimated)
Results: Posted 17 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
IDeg OD Flexible Dose	Experimental	Drug: insulin degludec
IDeg OD Fixed Dose	Experimental	Drug: insulin degludec
IDeg OD Simple	Experimental	Drug: insulin degludec
IDeg OD Stepwise	Experimental	Drug: insulin degludec

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
Body mass index (BMI) equal to or below 35 kg/m^2

Key exclusion criteria (5 listed)

Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludecIndividual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.	Drug	IDeg OD Fixed Dose, IDeg OD Flexible Dose, IDeg OD Simple, IDeg OD Stepwise
insulin degludecIndividual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.	Drug	IDeg OD Fixed Dose, IDeg OD Flexible Dose, IDeg OD Simple, IDeg OD Stepwise
insulin degludecIndividual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.	Drug	IDeg OD Fixed Dose, IDeg OD Flexible Dose, IDeg OD Simple, IDeg OD Stepwise

Primary outcome

Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
Time frame: Week 0, week 26
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)

8 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
Time frame: After 26 weeks of treatment
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))
Time frame: Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Time frame: Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period
Time frame: From Week 16 to end of trial (week 27)
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Time frame: Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period
Time frame: From week 16 to end of trial (week 27)

Results and safety

Results posted to the registry on 17 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDeg OD Fixed Dosing and Simple Titration (Arm A)	114	113
IDeg OD Fixed Dosing and Stepwise Titration (Arm B)	115	113
IDeg OD Flexible Dosing and Simple Titration (Arm C)	115	114
IDeg OD Flexible Dosing and Stepwise Titration (Arm D)	114	108

Primary outcome: Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: Percent (%) glycosylated haemoglobin

Measure	IDeg OD Flexible (Arm C+Arm D) n = 229	IDeg OD Fixed (Arm A+Arm B) n = 229	IDeg OD Simple (Arm A+Arm C) n = 229	IDeg OD Stepwise (Arm B+Arm D) n = 229
Value	-0.54 (0.76)	-0.62 (0.75)	-0.57 (0.72)	-0.59 (0.80)

Population analysed: The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: This included events from the first trial related activity after the subject had signed the informed consent and until the end of the follow-up period (Week 27).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDeg OD Flexible (Arm C+Arm D)	8 of 229 (3.5%)	79 of 229 (34.5%)	Not reported
IDeg OD Fixed (Arm A+Arm B)	6 of 229 (2.6%)	82 of 229 (35.8%)	Not reported
IDeg OD Simple (Arm A+Arm C)	7 of 229 (3.1%)	78 of 229 (34.1%)	Not reported
IDeg OD Stepwise (Arm B+Arm D)	7 of 229 (3.1%)	83 of 229 (36.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30603311Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial. Diabetol Int. 2016 Sep 2;8(1):87-94. doi: 10.1007/s13340-016-0284-9. eCollection 2017 Mar.
Results publication: PubMed 27182031Kadowaki T, Jinnouchi H, Kaku K, Herslov ML, Hyllested-Winge J, Nakamura S. Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial. J Diabetes Investig. 2016 Sep;7(5):711-7. doi: 10.1111/jdi.12502. Epub 2016 Apr 1.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

40 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 40 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) (time frame: Week 0, week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01880736, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.