DiabetesPhase 4NCT01215435

Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

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 1 site in Iran.

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 the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone. 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 1 siteIran
Study dates: Mar 2011to Sep 2012
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

Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
HbA1c at least 7.0 % - maximum 11 % at screening
Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
An antidiabetic regimen that has been stable for at least 3 months prior to screening
An antidiabetic regimen that includes a minimum of 2 OADs
OADs dosed at least 50% of the maximum recommended dose

Who cannot join

Known or suspected hypersensitivity to trial product(s) or related products
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
The receipt of any investigational medicinal product within one month prior to this trial
Suffer from a life threatening disease (cancer)
Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)

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Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
Recurrent hypoglycaemia or hypoglycaemic unawareness
Anemia (haemoglobin below 10 mg/dl)

Trial locations and contacts

1 site in 1 country.

Iran1 site

Study site
Tehran

Other trials in Iran

About this study

Official title: An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran

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
Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
biphasic insulin aspart 30Drug
Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

Study groups in NCT01215435
Study group	Role	What they receive
Pre-breakfast BIAsp 30	Experimental	Not described Receives: Drug: biphasic insulin aspart 30
Pre-dinner BIAsp 30	Experimental	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 in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
Measured: Week 0, Week 11

Secondary outcomes (2)

Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
Estimated mean change from baseline in FPG after 36 weeks of treatment
Measured: Week 0, Week 36
Number of Treatment Emergent Hypoglycaemic Episodes
A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
Measured: Week 0 to Week 36

Timeline

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

Mar 2011Sep 2012

First posted6 Oct 2010 (estimated)
Study startMar 2011
Primary completionSep 2012
Study completionSep 2012

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: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01215435
Sponsor's protocol ID: BIASP-3858
Other IDs: U1111-1116-2121
Status last verified: Oct 2014
First submitted: 1 Oct 2010
Last updated: 30 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 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran
ClinicalTrials.gov ID: NCT01215435
Acronym / sponsor ID: BIASP-3858
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 6 Oct 2010 (estimated)
Results: Posted 25 Nov 2013

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
Pre-breakfast BIAsp 30	Experimental	Drug: biphasic insulin aspart 30
Pre-dinner BIAsp 30	Experimental	Drug: biphasic insulin aspart 30

Who may qualify

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

Key inclusion criteria (6 listed)

Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
HbA1c at least 7.0 % - maximum 11 % at screening
Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
An antidiabetic regimen that has been stable for at least 3 months prior to screening
An antidiabetic regimen that includes a minimum of 2 OADs

Key exclusion criteria (9 listed)

Known or suspected hypersensitivity to trial product(s) or related products
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
The receipt of any investigational medicinal product within one month prior to this trial
Suffer from a life threatening disease (cancer)
Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening

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) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms	Drug	Pre-breakfast BIAsp 30
biphasic insulin aspart 30Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms	Drug	Pre-dinner BIAsp 30

Primary outcome

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
Time frame: Week 0, Week 11
Estimated mean change from baseline in HbA1c after 11 weeks of treatment

2 secondary outcomes

Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
Time frame: Week 0, Week 36
Number of Treatment Emergent Hypoglycaemic Episodes
Time frame: Week 0 to Week 36

Results and safety

Results posted to the registry on 25 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-breakfast BIAsp 30	122	103
Pre-dinner BIAsp 30	123	107

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11

Time frame: Week 0, Week 11. Mean (Standard Error). Unit: percentage of glycosylated haemoglobin

Measure	Pre-breakfast BIAsp 30 n = 122	Pre-dinner BIAsp 30 n = 123
Value	-1.04 (0.10)	-0.90 (0.10)

Pre-breakfast BIAsp 30 vs Pre-dinner BIAsp 30: Estimated treatment difference, Mean: -0.14 (95% CI -0.40 to 0.13), p <0.001, Regression, Linear

Population analysed: Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-breakfast BIAsp 30	3 of 122 (2.5%)	16 of 122 (13.1%)	Not reported
Pre-dinner BIAsp 30	4 of 123 (3.3%)	19 of 123 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 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 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Iran.

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 9 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 30 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 Iran. 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 25 Nov 2013). 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 (HbA1c) From Baseline to Week 11 (time frame: Week 0, Week 11). 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 NCT01215435.

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 30 Oct 2014.