DiabetesPhase 4NCT00537303

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

A Phase 4 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 12 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 Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in 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?: insulin detemir and insulin aspart
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 296 participants
Where: 69 sitesin 12 countries
Study dates: Oct 2007to Mar 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 mellitus for more than 6 months
HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
BMI (Body Mass Index) less than 40 kg/m2
Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
Treatment with one to 3 OADs

Who cannot join

Known or suspected allergy to trial products or related products
Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
Previous participation in any trial including this for the last 6 months
Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Trial locations and contacts

69 sites in 12 countries.

Country

City, postcode or hospital

69 sites in 12 countries

United States20 sites

Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Des Moines, Iowa, 50314-3027
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mission Viejo, California, 92691
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
San Antonio, Texas, 78229

Other trials in United States

Spain7 sites

Novo Nordisk Investigational Site
Cáceres, 10004
Novo Nordisk Investigational Site
Inca, 07300
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Málaga, 29010
Novo Nordisk Investigational Site
Mérida, 06800
Novo Nordisk Investigational Site
Mostoles - Madrid -, 28935
Novo Nordisk Investigational Site
Santiago de Compostela, 15706

Other trials in Spain

United Kingdom7 sites

Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Coventry, CV2 2DX
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
Llanelli, SA14 8QF
Novo Nordisk Investigational Site
Llantrisant, CF72 8XR
Novo Nordisk Investigational Site
Reading, RG7 3SQ
Novo Nordisk Investigational Site
Rugby, CV22 5PX

Other trials in United Kingdom

Finland6 sites

Novo Nordisk Investigational Site
Espoo, FI-02650
Novo Nordisk Investigational Site
Oulu, FI-90100
Novo Nordisk Investigational Site
Oulu, FI-90220
Novo Nordisk Investigational Site
Tampere, 33100
Novo Nordisk Investigational Site
Vaasa, FIN-61500
Novo Nordisk Investigational Site
Vantaa, FI-01620

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Netherlands6 sites

Novo Nordisk Investigational Site
's-Hertogenbosch, 5216 GC
Novo Nordisk Investigational Site
Eindhoven, 5631 BM
Novo Nordisk Investigational Site
Etten-Leur, 4872 LP
Novo Nordisk Investigational Site
Hulst, 4561 NV
Novo Nordisk Investigational Site
Utrecht, 3563 AZ
Novo Nordisk Investigational Site
Woerden, 3443 GG

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Norway6 sites

Novo Nordisk Investigational Site
Jessheim, 2050
Novo Nordisk Investigational Site
Oslo, 0160
Novo Nordisk Investigational Site
Sarpsborg, 1702
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Tønsberg, 3116
Novo Nordisk Investigational Site
Tromsø, 9038

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France5 sites

Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Pointe à Pitre, 97159
Novo Nordisk Investigational Site
Vénissieux, 69200

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Russia3 sites

Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Moscow, 123448
Novo Nordisk Investigational Site
Moscow, 127644

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South Africa3 sites

Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1818
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1829
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0001

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Sweden3 sites

Novo Nordisk Investigational Site
Ängelholm, 262 91
Novo Nordisk Investigational Site
Gothenburg, 417 17
Novo Nordisk Investigational Site
Mölndal, 431 80

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Serbia and Montenegro2 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Nis, 18000

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Denmark1 site

Novo Nordisk Investigational Site
Århus C, 8000

Other trials in Denmark

About this study

Official title: Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, insulin aspart
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.

insulin detemirDrug
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
insulin aspartDrug
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
insulin aspartDrug
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

Study groups in NCT00537303
Study group	Role	What they receive
Advanced	Experimental	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. Receives: Drug: insulin detemir; Drug: insulin aspart
Basic	Active comparator	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively. Receives: Drug: insulin detemir; Drug: insulin aspart

What is being measured

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

Glycosylated Haemoglobin A1c (HbA1c)
Analysed for the full analysis set.
Measured: week 36
Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol analysis set.
Measured: week 36

Secondary outcomes (4)

Hypoglycaemic Episodes
Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Measured: Weeks 0-36
Biochemistry: Serum Alanine Aminotransferase
Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.
Measured: week 36
Haematology: Haemoglobin Measured in Blood
Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.
Measured: week 36
Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide
High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.
Measured: week 36

Timeline

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

Oct 2007Mar 2009

First posted1 Oct 2007 (estimated)
Study startOct 2007
Primary completionMar 2009
Study completionMar 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.
Publications (1)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: 296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537303
Sponsor's protocol ID: NN304-1833
Other IDs: 2007-000123-18
Status last verified: Jan 2017
First submitted: 28 Sep 2007
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.
PubMed 21550957

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 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00537303
Acronym / sponsor ID: NN304-1833
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 296 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 1 Oct 2007 (estimated)
Results: Posted 13 Aug 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 Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Study design

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

Arm	Type	Receives
Advanced	Experimental	Drug: insulin detemir, Drug: insulin aspartInsulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Basic	Active comparator	Drug: insulin detemir, Drug: insulin aspartInsulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

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 mellitus for more than 6 months
HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
BMI (Body Mass Index) less than 40 kg/m2
Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
Treatment with one to 3 OADs

Key exclusion criteria (4 listed)

Known or suspected allergy to trial products or related products
Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
Previous participation in any trial including this for the last 6 months
Use of more than 1 U/kg of basal insulin daily at trial initiation (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
insulin detemirTreat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)	Drug	Advanced, Basic
insulin aspartAdministered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)	Drug	Advanced
insulin aspartAdministered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)	Drug	Basic

Primary outcome

Glycosylated Haemoglobin A1c (HbA1c)
Time frame: week 36
Analysed for the full analysis set.
Glycosylated Haemoglobin A1c (HbA1c)
Time frame: week 36
Measured for the Per Protocol analysis set.

4 secondary outcomes

Hypoglycaemic Episodes
Time frame: Weeks 0-36
Biochemistry: Serum Alanine Aminotransferase
Time frame: week 36
Haematology: Haemoglobin Measured in Blood
Time frame: week 36
Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide
Time frame: week 36

Results and safety

Results posted to the registry on 13 Aug 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
Advanced	146	120
Basic	150	125

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c)

Time frame: week 36. Least squares mean (Standard Error). Unit: percentage (%) of total haemoglobin

Measure	Advanced n = 140	Basic n = 147
Value	7.67 (0.09)	7.61 (0.08)

Advanced vs Basic: Mean Difference (Final Values): 0.06 (95% CI -0.17 to 0.29), p = 0.606, ANCOVA

Population analysed: Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c)

Time frame: week 36. Least squares mean (Standard Error). Unit: percentage (%) of total haemoglobin

Measure	Advanced n = 107	Basic n = 118
Value	7.55 (0.09)	7.52 (0.08)

Advanced vs Basic: Mean Difference (Final Values): 0.03 (95% CI -0.21 to 0.26), p = 0.816, ANCOVA

Population analysed: Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a timeframe of 36 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advanced	4 of 146 (2.7%)	54 of 146 (37%)	Not reported
Basic	8 of 150 (5.3%)	58 of 150 (38.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21550957Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

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Active, not 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

69 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 12 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 5 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 10 Mar 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 United States, Spain, United Kingdom, Finland, Netherlands and 7 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 13 Aug 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: week 36). The study lists 2 primary outcomes in all. 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 NCT00537303, which also lists 1 linked publication.

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 10 Mar 2017.