DiabetesPhase 4NCT00669864

Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

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. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin. Read more about this study

Who is it for?: Ages 18 years and older
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: 293 participants
Where: 1 siteChina
Study dates: Nov 2007to Apr 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
BMI (Body Mass Index) maximum 40 kg/m2

Who cannot join

Metformin contraindications according to local practice
Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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
Also called NovoMix® 30
Subcutaneous (under the skin) injection, twice daily
metforminDrug
Tablets, 1000 - 2000 mg daily

Study groups in NCT00669864
Study group	Role	What they receive
BIAsp 30-30	Experimental	Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily 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 HbA1c (Glycosylated Haemoglobin A1c)
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Measured: week 0, week 16

Secondary outcomes (5)

Change in 8-point Plasma Glucose Profile
Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
Measured: week 0, week 16
Percentage of Subjects Achieving HbA1c Less Than 7.0%
Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
Measured: week 16
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
Measured: week 16
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Measured: weeks 0-16
Hypoglycaemic Episodes, Diurnal/Nocturnal
Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).
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.

Nov 2007Apr 2009

First posted1 May 2008 (estimated)
Study startNov 2007
Primary completionApr 2009
Study completionApr 2009

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00669864
Sponsor's protocol ID: BIASP-1960
Status last verified: Mar 2016
First submitted: 29 Apr 2008
Last updated: 1 Apr 2016
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 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
ClinicalTrials.gov ID: NCT00669864
Acronym / sponsor ID: BIASP-1960
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 293 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 1 May 2008 (estimated)
Results: Posted 5 Jul 2010

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BIAsp 30-30	Experimental	Drug: biphasic insulin aspart 30, Drug: metforminIndividual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes
Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
BMI (Body Mass Index) maximum 40 kg/m2

Key exclusion criteria (2 listed)

Metformin contraindications according to local practice
Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this 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 30Also: NovoMix® 30Subcutaneous (under the skin) injection, twice daily	Drug	BIAsp 30-30
metforminTablets, 1000 - 2000 mg daily	Drug	BIAsp 30-30

Primary outcome

Change in HbA1c (Glycosylated Haemoglobin A1c)
Time frame: week 0, week 16
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)

5 secondary outcomes

Change in 8-point Plasma Glucose Profile
Time frame: week 0, week 16
Percentage of Subjects Achieving HbA1c Less Than 7.0%
Time frame: week 16
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time frame: week 16
Hypoglycaemic Episodes
Time frame: weeks 0-16
Hypoglycaemic Episodes, Diurnal/Nocturnal
Time frame: weeks 0-16

Results and safety

Results posted to the registry on 5 Jul 2010, 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 30-30	293	284

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin A1c)

Time frame: week 0, week 16. Mean (Standard Error). Unit: percentage (%) of total haemoglobin

Measure	BIAsp 30-30 n = 293
Value	-1.303 (0.056)

BIAsp 30-30: Estimated mean: -1.303 (95% CI -1.414 to -1.192), p <0.0001, t-test, 1 sided

Population analysed: Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time span of 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIAsp 30-30	0 of 293 (0%)	80 of 293 (27.3%)	Not reported

Limitations and caveats (from the sponsor): This single-armed trial does not permit a comprehensive comparison between BIAsp30 and basal insulin. Otherwise, this could have proffered greater clarity on the putative benefits that BIAsp30 brings to subjects with type 2 diabetes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

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Type 2 Diabetes
Active, not recruiting
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Recruiting
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Recruiting
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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 4 inclusion and 2 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 1 Apr 2016. 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 5 Jul 2010). 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 HbA1c (Glycosylated Haemoglobin A1c) (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 NCT00669864.

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 1 Apr 2016.