DiabetesPhase 4NCT01892020

Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

A Phase 4 study testing biphasic insulin aspart 50 and biphasic human insulin 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 aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: biphasic insulin aspart 50 and biphasic human insulin 50
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 1 siteChina
Study dates: Jun 2013to May 2014
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)

Who cannot join

Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
Previous use of any insulin other than premixed human insulin 50 BID within 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

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: A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart 50, biphasic human insulin 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 50Drug
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
biphasic human insulin 50Drug
Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.

Study groups in NCT01892020
Study group	Role	What they receive
Treatment sequence 1 (Group A)	Experimental	Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2) Receives: Drug: biphasic insulin aspart 50; Drug: biphasic human insulin 50
Treatment sequence 2 (Group B)	Experimental	Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2) Receives: Drug: biphasic insulin aspart 50; Drug: biphasic human insulin 50

What is being measured

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

2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.
Measured: After 4 weeks of treatment in each treatment sequence

Secondary outcomes (6)

-1-hour PPG Increment Following a Standard Meal Test
The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.
Measured: After 4 weeks of treatment in each treatment sequence
-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test
AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.
Measured: After 4 weeks of treatment in each treatment sequence
2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile
PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.
Measured: After 4 weeks of treatment in each treatment sequence
The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile
Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.
Measured: After 4 weeks of treatment in each treatment sequence
Incidence of Hypoglycemic Episodes
Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.
Measured: During 4 weeks of treatment in each treatment sequence
Incidence of AEs (Adverse Event)
Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.
Measured: During 4 weeks of treatment in each treatment sequence

Timeline

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

Jun 2013May 2014

First posted3 Jul 2013 (estimated)
Study startJun 2013
Primary completionMay 2014
Study completionMay 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.
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: Crossover
Masking: None (open label)
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01892020
Sponsor's protocol ID: BIASP-4058
Other IDs: U1111-1137-2342
Status last verified: Jun 2015
First submitted: 28 Jun 2013
Last updated: 9 Jul 2015
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?

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01892020
Acronym / sponsor ID: BIASP-4058
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 3 Jul 2013 (estimated)
Results: Posted 9 Jul 2015

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: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment sequence 1 (Group A)	Experimental	Drug: biphasic insulin aspart 50, Drug: biphasic human insulin 50Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2)
Treatment sequence 2 (Group B)	Experimental	Drug: biphasic insulin aspart 50, Drug: biphasic human insulin 50Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)

Key exclusion criteria (3 listed)

Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
Previous use of any insulin other than premixed human insulin 50 BID within 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

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 50Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.	Drug	Treatment sequence 1 (Group A), Treatment sequence 2 (Group B)
biphasic human insulin 50Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.	Drug	Treatment sequence 1 (Group A), Treatment sequence 2 (Group B)

Primary outcome

2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test
Time frame: After 4 weeks of treatment in each treatment sequence
The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.

6 secondary outcomes

-1-hour PPG Increment Following a Standard Meal Test
Time frame: After 4 weeks of treatment in each treatment sequence
-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test
Time frame: After 4 weeks of treatment in each treatment sequence
2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile
Time frame: After 4 weeks of treatment in each treatment sequence
The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile
Time frame: After 4 weeks of treatment in each treatment sequence
Incidence of Hypoglycemic Episodes
Time frame: During 4 weeks of treatment in each treatment sequence
Incidence of AEs (Adverse Event)
Time frame: During 4 weeks of treatment in each treatment sequence

Results and safety

Results posted to the registry on 9 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (BIAsp 50 - BHI 50)	81	78
Group B (BHI 50 - BIAsp 50)	80	74

Primary outcome: 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test

Time frame: After 4 weeks of treatment in each treatment sequence. Mean (Standard Deviation). Unit: mmol/L

Measure	BIAsp 50 n = 152	BHI 50 n = 149
Value	5.30 (3.17)	6.41 (2.83)

BIAsp 50 vs BHI 50: Mean Difference (Net): -1.12 (95% CI -1.66 to -0.58), p < 0.001, Mixed Models Analysis

Population analysed: Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: An event with onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment was defined as treatment emergent AE. All events meeting this definition were collected and reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIAsp 50	1 of 155 (0.6%)	8 of 155 (5.2%)	Not reported
BHI 50	1 of 158 (0.6%)	2 of 158 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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 50 and biphasic human insulin 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 4 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 9 Jul 2015. 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 9 Jul 2015). 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?

2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test (time frame: After 4 weeks of treatment in each treatment sequence). 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 NCT01892020.

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 9 Jul 2015.