DiabetesPhase 3NCT00627445

Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

A Phase 3 study testing biphasic insulin aspart 30, metformin and biphasic insulin aspart 50 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 trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin. 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, metformin and biphasic insulin aspart 50
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 441 participants
Where: 1 siteChina
Study dates: Feb 2008to Jan 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Who cannot join

Metformin contraindications according to local practice
Systemic use of TZDs (thiazolidinediones) for more than 1 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

Official title: Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 30, metformin, biphasic insulin aspart 50
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
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
metforminDrug
Tablets, 500 - 2000 mg, once, twice or three times daily
biphasic insulin aspart 50Drug
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

Study groups in NCT00627445
Study group	Role	What they receive
BIAsp 50-50-30	Experimental	Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin Receives: Drug: biphasic insulin aspart 30; Drug: metformin; Drug: biphasic insulin aspart 50
BIAsp 30-30	Active comparator	Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin 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)
Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)
Measured: week 0, week 16

Secondary outcomes (7)

The Percentage of Subjects Achieving HbA1c Treatment Targets
The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.
Measured: week 16
Change and Daily Average in 8-point Plasma Glucose
Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.
Measured: week 0, week 16
Change and Daily Average in Prandial Plasma Glucose Increment
Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.
Measured: week 0, week 16
The Total Increase in Total Daily Insulin Dose Per Body Weight
The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).
Measured: week 0, week 16
Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 16)
Measured: week 0, week 16
Number of Hypoglycaemic Episodes
Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. 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
Number of Nocturnal Hypoglycaemic Episodes
Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. 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

Timeline

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

Feb 2008Jan 2009

First posted3 Mar 2008 (estimated)
Study startFeb 2008
Primary completionJan 2009
Study completionJan 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 441 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00627445
Sponsor's protocol ID: BIASP-1858
Status last verified: Oct 2014
First submitted: 22 Feb 2008
Last updated: 22 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 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00627445
Acronym / sponsor ID: BIASP-1858
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 441 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 3 Mar 2008 (estimated)
Results: Posted 31 Mar 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BIAsp 50-50-30	Experimental	Drug: biphasic insulin aspart 30, Drug: metformin, Drug: biphasic insulin aspart 50Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
BIAsp 30-30	Active comparator	Drug: biphasic insulin aspart 30, Drug: metforminBiphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

Who may qualify

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

Key inclusion criteria (5 listed)

Type 2 diabetes
Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Key exclusion criteria (2 listed)

Metformin contraindications according to local practice
Systemic use of TZDs (thiazolidinediones) for more than 1 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 30Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner	Drug	BIAsp 30-30, BIAsp 50-50-30
metforminTablets, 500 - 2000 mg, once, twice or three times daily	Drug	BIAsp 30-30, BIAsp 50-50-30
biphasic insulin aspart 50Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch	Drug	BIAsp 50-50-30

Primary outcome

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

7 secondary outcomes

The Percentage of Subjects Achieving HbA1c Treatment Targets
Time frame: week 16
Change and Daily Average in 8-point Plasma Glucose
Time frame: week 0, week 16
Change and Daily Average in Prandial Plasma Glucose Increment
Time frame: week 0, week 16
The Total Increase in Total Daily Insulin Dose Per Body Weight
Time frame: week 0, week 16
Change in Body Weight
Time frame: week 0, week 16
Number of Hypoglycaemic Episodes
Time frame: weeks 0-16
Number of Nocturnal Hypoglycaemic Episodes
Time frame: weeks 0-16

Results and safety

Results posted to the registry on 31 Mar 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 50-50-30	219	210
BIAsp 30-30	222	210

Primary outcome: Change in Glycosylated Haemoglobin A1c (HbA1c)

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

Measure	BIAsp 50-50-30 n = 216	BIAsp 30-30 n = 221
Value	-1.790 (0.057)	-1.517 (0.056)

Population analysed: Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of trial product.

7 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
BIAsp 50-50-30	5 of 219 (2.3%)	74 of 219 (33.8%)	Not reported
BIAsp 30-30	9 of 222 (4.1%)	68 of 222 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 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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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 3 study testing biphasic insulin aspart 30, metformin and biphasic insulin aspart 50 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 5 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 22 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 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 31 Mar 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 Glycosylated Haemoglobin A1c (HbA1c) (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 NCT00627445.

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 22 Oct 2014.