DiabetesPhase 4NCT01278160

Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

A Phase 4 study testing biphasic insulin aspart 30 and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site 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 the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in… Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: biphasic insulin aspart 30 and metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 179 participants
Where: 1 siteChina
Study dates: Jan 2011to Sep 2011
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
HbA1c above or equal to 7.0%
Body Mass Index (BMI) below or equal to 40.0 kg/m2

Who cannot join

Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
Known proliferative retinopathy or maculopathy requiring acute treatment
Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 30, metformin
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
Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.
biphasic insulin aspart 30Drug
Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.
metforminDrug
Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged

Study groups in NCT01278160
Study group	Role	What they receive
BIAsp 30 (2:1)	Experimental	After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals Receives: Drug: biphasic insulin aspart 30; Drug: metformin
BIAsp 30 (1:1)	Experimental	After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals Receives: Drug: biphasic insulin aspart 30; Drug: metformin

What is being measured

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

Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
Measured: Week 0, week 16

Secondary outcomes (4)

9-point SMPG (Self Measured Plasma Glucose) Profile
A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day
Measured: Week 16
Percentage of Subjects Achieving HbA1c Below 7.0%
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment
Measured: Week 16
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment
Measured: Week 16
Number of Treatment Emergent Hypoglycaemic Episodes
Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).
Measured: Weeks 0-16

Timeline

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

Jan 2011Sep 2011

First posted17 Jan 2011 (estimated)
Study startJan 2011
Primary completionSep 2011
Study completionSep 2011

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.
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: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01278160
Sponsor's protocol ID: BIASP-3883
Other IDs: U1111-1118-0330
Status last verified: Oct 2014
First submitted: 14 Jan 2011
Last updated: 27 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients
ClinicalTrials.gov ID: NCT01278160
Acronym / sponsor ID: BIASP-3883
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 17 Jan 2011 (estimated)
Results: Posted 18 Oct 2012

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
BIAsp 30 (2:1)	Experimental	Drug: biphasic insulin aspart 30, Drug: metforminAfter discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
BIAsp 30 (1:1)	Experimental	Drug: biphasic insulin aspart 30, Drug: metforminAfter discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
HbA1c above or equal to 7.0%
Body Mass Index (BMI) below or equal to 40.0 kg/m2

Key exclusion criteria (3 listed)

Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
Known proliferative retinopathy or maculopathy requiring acute treatment
Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

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 30Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.	Drug	BIAsp 30 (2:1)
biphasic insulin aspart 30Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.	Drug	BIAsp 30 (1:1)
metforminTablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged	Drug	BIAsp 30 (1:1), BIAsp 30 (2:1)

Primary outcome

Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline
Time frame: Week 0, week 16

4 secondary outcomes

9-point SMPG (Self Measured Plasma Glucose) Profile
Time frame: Week 16
Percentage of Subjects Achieving HbA1c Below 7.0%
Time frame: Week 16
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time frame: Week 16
Number of Treatment Emergent Hypoglycaemic Episodes
Time frame: Weeks 0-16

Results and safety

Results posted to the registry on 18 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIAsp 30 (2:1)	89	84
BIAsp 30 (1:1)	90	84

Primary outcome: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline

Time frame: Week 0, week 16. Least squares mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	BIAsp 30 (2:1) n = 86	BIAsp 30 (1:1) n = 87
Value	-0.13 (0.08)	-0.12 (0.08)

BIAsp 30 (2:1) vs BIAsp 30 (1:1): Mean Difference (Net): -0.01 (95% CI -0.24 to 0.22), ANCOVA

Population analysed: Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a timespan of 17 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIAsp 30 (2:1)	1 of 89 (1.1%)	0 of 89 (0%)	Not reported
BIAsp 30 (1:1)	2 of 90 (2.2%)	0 of 90 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

1 site 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 and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site 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 3 inclusion and 3 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 18 Oct 2012). 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 in Glycosylated Haemoglobin A1c (HbA1c) From Baseline (time frame: Week 0, week 16). 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 NCT01278160.

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 27 Oct 2014.