DiabetesPhase 4NCT00469092

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

A Phase 4 study testing biphasic insulin aspart, insulin glargine and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes. 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, insulin glargine and metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 69 sitesin 15 countries
Study dates: May 2007to Apr 2008
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
Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
Ongoing stable treatment with metformin for at least 2 months
Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
Insulin naive
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Who cannot join

Metformin contraindication according to local practice
TZD (thiazolidinedione) treatment for the last 5 months before trial start
Systemic treatment with any corticosteroid 3 months before trial start
Any disease or condition which according to the Investigator would interfere with the trial

Trial locations and contacts

69 sites in 15 countries.

Country

City, postcode or hospital

69 sites in 15 countries

Poland14 sites

Novo Nordisk Investigational Site
Bialystok, 15-276
Novo Nordisk Investigational Site
Bydgoszcz, 85-094
Novo Nordisk Investigational Site
Gdansk, 80-858
Novo Nordisk Investigational Site
Gdynia, 81-366
Novo Nordisk Investigational Site
Krakow, 31-501
Novo Nordisk Investigational Site
Lodz, 90-153
Novo Nordisk Investigational Site
Lubin, 59-301
Novo Nordisk Investigational Site
Lublin, 20-081
Novo Nordisk Investigational Site
Olsztyn, 10-561
Novo Nordisk Investigational Site
Poznan, 60-821
Novo Nordisk Investigational Site
Rzeszów, 35-301
Novo Nordisk Investigational Site
Szczecin, 71-455
Novo Nordisk Investigational Site
Warsaw, 02-507
Novo Nordisk Investigational Site
Zabrze, 41-800

Other trials in Poland

France6 sites

Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Limoges, 87042
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Pointe à Pitre, 97159

Other trials in France

Austria5 sites

Novo Nordisk Investigational Site
Bregenz, A - 6900
Novo Nordisk Investigational Site
Feldkirch, 6807
Novo Nordisk Investigational Site
Traisen, 3160
Novo Nordisk Investigational Site
Vienna, 1100
Novo Nordisk Investigational Site
Wels, 4600

Other trials in Austria

Netherlands5 sites

Novo Nordisk Investigational Site
Almere Stad, 1311RL
Novo Nordisk Investigational Site
Groningen, 9711 SG
Novo Nordisk Investigational Site
Leiderdorp, 2352 RA
Novo Nordisk Investigational Site
Rotterdam, 3021 HC
Novo Nordisk Investigational Site
Zoetermeer, 2724 EK

Other trials in Netherlands

Romania5 sites

Novo Nordisk Investigational Site
Botoșani, 710224
Novo Nordisk Investigational Site
Bucharest, 020475
Novo Nordisk Investigational Site
Galati, 800371
Novo Nordisk Investigational Site
Satu Mare, Satu Mare County, 440055
Novo Nordisk Investigational Site
Targoviste, 130083

Other trials in Romania

Argentina4 sites

Novo Nordisk Investigational Site
Buenos Aires, C1181ACH
Novo Nordisk Investigational Site
Ciudad Autonoma de Bs As, C1405CWB
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, C1406FWY
Novo Nordisk Investigational Site
Mar del Plata, B7602CBM

Other trials in Argentina

India4 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380006
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560043
Novo Nordisk Investigational Site
Karnāl, Haryana, 132001
Novo Nordisk Investigational Site
Visakhapatnam, 530001

Other trials in India

South Africa4 sites

Novo Nordisk Investigational Site
Bloemfontein, Free State, 9301
Novo Nordisk Investigational Site
Brits, North West, 0250
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091

Other trials in South Africa

Spain4 sites

Novo Nordisk Investigational Site
Alzira, 46600
Novo Nordisk Investigational Site
Madrid, 28040
Novo Nordisk Investigational Site
Madrid, 28041
Novo Nordisk Investigational Site
Málaga, 29009

Other trials in Spain

Sweden4 sites

Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Stockholm, 182 88

Other trials in Sweden

Malaysia3 sites

Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Pulau Pinang, 10990

Other trials in Malaysia

Mexico3 sites

Novo Nordisk Investigational Site
Guadalajara, 44600
Novo Nordisk Investigational Site
Guadalajara, 44620
Novo Nordisk Investigational Site
Pachuca, 42060

Other trials in Mexico

Philippines3 sites

Novo Nordisk Investigational Site
Manila, 1014
Novo Nordisk Investigational Site
Quezon City, 1100
Novo Nordisk Investigational Site
Quezon City, 1102

Other trials in Philippines

Serbia and Montenegro3 sites

Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Nis, 18000
Novo Nordisk Investigational Site
Novi Sad, 21000

Other trials in Serbia and Montenegro

Czechia2 sites

Novo Nordisk Investigational Site
Brno, 656 91
Novo Nordisk Investigational Site
Hradec Králové, 500 05

Other trials in Czechia

About this study

Official title: A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: biphasic insulin aspart, insulin glargine, metformin, glimepiride
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 aspartDrug
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
insulin glargineDrug
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
metforminDrug
Tablets, 2550 mcg. Administered once daily.
glimepirideDrug
Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Study groups in NCT00469092
Study group	Role	What they receive
BIAsp 30	Experimental	Not described Receives: Drug: biphasic insulin aspart; Drug: metformin; Drug: glimepiride
Glargine	Active comparator	Not described Receives: Drug: insulin glargine; Drug: metformin; Drug: glimepiride

What is being measured

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

Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
Measured: After 26 weeks of treatment

Secondary outcomes (5)

9-point Self-measured Plasma Glucose Profiles
Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. 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.
Measured: After 26 weeks of treatment
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.
Measured: After 26 weeks of treatment
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
Measured: After 26 weeks of treatment
Number of Hypoglycaemic Episodes
Total number of hypoglycaemic episodes experienced in each treatment arm. 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 0-26
Number of Subjects Reporting Treatment Emergent Adverse Events
Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.
Measured: Weeks 0-26

Timeline

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

May 2007Apr 2008

First posted4 May 2007 (estimated)
Study startMay 2007
Primary completionApr 2008
Study completionApr 2008

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.
Publications (2)Papers the sponsor has linked to this study.
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: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00469092
Sponsor's protocol ID: BIASP-1731
Other IDs: 2006-003288-29
Status last verified: Jan 2017
First submitted: 3 May 2007
Last updated: 23 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.
PubMed 19821654
Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.
PubMed 20363044

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00469092
Acronym / sponsor ID: BIASP-1731
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 4 May 2007 (estimated)
Results: Posted 6 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BIAsp 30	Experimental	Drug: biphasic insulin aspart, Drug: metformin, Drug: glimepiride
Glargine	Active comparator	Drug: insulin glargine, Drug: metformin, Drug: glimepiride

Who may qualify

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

Key inclusion criteria (6 listed)

Type 2 diabetes
Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
Ongoing stable treatment with metformin for at least 2 months
Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
Insulin naive

Key exclusion criteria (4 listed)

Metformin contraindication according to local practice
TZD (thiazolidinedione) treatment for the last 5 months before trial start
Systemic treatment with any corticosteroid 3 months before trial start
Any disease or condition which according to the Investigator 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 aspartTreat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.	Drug	BIAsp 30
insulin glargineTreat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.	Drug	Glargine
metforminTablets, 2550 mcg. Administered once daily.	Drug	BIAsp 30, Glargine
glimepirideTablets 2 mg. 4, 6 or 8 mg administered once daily.	Drug	BIAsp 30, Glargine

Primary outcome

Glycosylated Haemoglobin A1c (HbA1c)
Time frame: After 26 weeks of treatment
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.

5 secondary outcomes

9-point Self-measured Plasma Glucose Profiles
Time frame: After 26 weeks of treatment
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
Time frame: After 26 weeks of treatment
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Time frame: After 26 weeks of treatment
Number of Hypoglycaemic Episodes
Time frame: Weeks 0-26
Number of Subjects Reporting Treatment Emergent Adverse Events
Time frame: Weeks 0-26

Results and safety

Results posted to the registry on 6 Jan 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	239	213
Glargine	241	220

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c)

Time frame: After 26 weeks of treatment. Least squares mean (Standard Deviation). Unit: percentage of total haemoglobin

Measure	BIAsp 30 n = 225	Glargine n = 232
Value	7.08 (0.07)	7.23 (0.07)

BIAsp 30 vs Glargine: Mean Difference (Net): -0.16 (95% CI -0.30 to -0.02), p = 0.029, Regression, Linear

Population analysed: Intention to Treat (Last Observation Carried Forward) population. All randomised subjects exposed to trial drug, and who had at least a baseline HbA1c measurement and at least one post randomisation HbA1c measurement.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event were collected in a time span of 26 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BIAsp 30	13 of 231 (5.6%)	56 of 231 (24.2%)	Not reported
Glargine	10 of 238 (4.2%)	63 of 238 (26.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19821654Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.
Results publication: PubMed 20363044Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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

69 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biphasic insulin aspart, insulin glargine and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 15 countries.

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 4 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Poland, France, Austria, Netherlands, Romania and 10 more countries. 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 6 Jan 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?

Glycosylated Haemoglobin A1c (HbA1c) (time frame: After 26 weeks of treatment). 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 NCT00469092, which also lists 2 linked publications.

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 23 Feb 2017.