DiabetesPhase 4NCT01618214

Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

A Phase 4 study testing biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 22 sites in China.

Completed

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

Official record

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Trial summary

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: biphasic insulin aspart 30
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 344 participants
Where: 22 sitesChina
Study dates: Jun 2012to Jan 2013
Phase: Phase 4
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
Total daily insulin dose below 1.4 IU/Kg
HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Who cannot join

Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

China22 sites

Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100029
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100088
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100700
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730
Novo Nordisk Investigational Site
Changchun, Jilin, 130041
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 400010
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 404000
Novo Nordisk Investigational Site
Guangzhou, Guangdong, 510080
Novo Nordisk Investigational Site
Hangzhou, Zhejiang, 310003
Novo Nordisk Investigational Site
Hefei, Anhui, 230001
Novo Nordisk Investigational Site
Hefei, Anhui, 230022
Novo Nordisk Investigational Site
Jinan, Shandong, 250013
Novo Nordisk Investigational Site
Nanchang, Jiangxi, 330006
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210011
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200072
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, 050051
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, 050082
Novo Nordisk Investigational Site
Siping, Jilin, 136000
Novo Nordisk Investigational Site
Tongliao, Inner Mongolia, 028007
Novo Nordisk Investigational Site
Wuhan, Hubei, 430034
Novo Nordisk Investigational Site
Xi'an, Shaanxi, 710032
Novo Nordisk Investigational Site
Yangzhou, Jiangsu, 225001

Other trials in China

About this study

Official title: A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 30
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.

biphasic insulin aspart 30Drug
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.

Study groups in NCT01618214
Study group	Role	What they receive
Subject-driven titration	Experimental	Not described Receives: Drug: biphasic insulin aspart 30
Investigator-driven titration	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30

What is being measured

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

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Measured: Week 0, week 20

Secondary outcomes (4)

Percentage of Subjects Achieving HbA1c Below 7.0%
Measured: After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Measured: After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Measured: Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
Measured: Week 0 to week 20 (inclusive).

Timeline

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

Jun 2012Jan 2013

First posted13 Jun 2012 (estimated)
Study startJun 2012
Primary completionJan 2013
Study completionJan 2013

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 (1)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01618214
Sponsor's protocol ID: BIASP-3984
Other IDs: U1111-1126-7610
Status last verified: Jan 2017
First submitted: 11 Jun 2012
Last updated: 24 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.
PubMed 26816605

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 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin
ClinicalTrials.gov ID: NCT01618214
Acronym / sponsor ID: BIASP-3984
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 13 Jun 2012 (estimated)
Results: Posted 8 May 2014

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: 2

Arm	Type	Receives
Subject-driven titration	Experimental	Drug: biphasic insulin aspart 30
Investigator-driven titration	Active comparator	Drug: biphasic insulin aspart 30

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
Total daily insulin dose below 1.4 IU/Kg
HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)

Key exclusion criteria (5 listed)

Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment

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
biphasic insulin aspart 30Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.	Drug	Investigator-driven titration, Subject-driven titration

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 20
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).

4 secondary outcomes

Percentage of Subjects Achieving HbA1c Below 7.0%
Time frame: After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time frame: After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Time frame: Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Time frame: Week 0 to week 20 (inclusive).

Results and safety

Results posted to the registry on 8 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subject-driven Titration	172	162
Investigator-driven Titration	172	159

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

Time frame: Week 0, week 20. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	Subject-driven Titration n = 168	Investigator-driven Titration n = 170
Value	-1.32 (0.86)	-1.31 (0.96)

Subject-driven Titration vs Investigator-driven Titration: Mean Difference (Final Values): -0.02 (95% CI -0.19 to 0.14), Regression, Linear

Population analysed: Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The reported treatment emergent adverse event was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment, up to 20 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subject-driven Titration	4 of 172 (2.3%)	1 of 172 (0.6%)	Not reported
Investigator-driven Titration	7 of 172 (4.1%)	13 of 172 (7.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26816605Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 22 sites in China.

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 6 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 24 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 22 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 May 2014). 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 20). 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 NCT01618214, which also lists 1 linked publication.

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 24 Feb 2017.