DiabetesPhase 3NCT00447382
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
A Phase 3 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 5 sites in 5 countries.
Trial summary
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin detemir and insulin aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Mar 2007to Jul 2008
- 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 1 diabetes for at least 12 months
- Basal-bolus treatment for at least 3 months
- Body Mass Index (BMI) less than or equal to 35.0 kg/m^2
- HbA1c (glycosylated haemoglobin) less than or equal to 12.0%
Who cannot join
- Known or suspected allergy to trial products or related products
- Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
- Receipt of any trial drug within 1 month prior to this trial
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bolus Regimen With Insulin Aspart as the Bolus Insulin
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
NN304 injected s.c. (under the skin). Given as basal insulin.
insulin aspartDrug
Injected s.c. (under the skin). Given as bolus insulin.
insulin detemirDrug
NN729 injected s.c. (under the skin). Given as basal insulin
| Study group | Role | What they receive |
|---|---|---|
| NN304 | Active comparator | Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks Receives: Drug: insulin detemir; Drug: insulin aspart |
| NN729 | Experimental | Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks Receives: Drug: insulin aspart; Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Measured: week 0, week 52
Secondary outcomes (23)
Hypoglycaemic Episodes
Number of hypoglycaemic episodes from Week 0 to Week 52, 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. 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. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.
Measured: Weeks 0-52
Glycaemic Control Parameters (Change in HbA1c)
HbA1c (Glycosylated haemoglobin).
Measured: week 0, week 52
Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
Measured: week 0, week 52
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
- point is Before Breakfast
- point is 120 minutes after Breakfast
- point is Before Lunch
- point is 120 minutes after Lunch
- point is Before Dinner
- point is 120 minutes after Dinner
- point is at Bedtime
- point is At 03:00 A.M.
- point is Before Breakfast the Following Day
Measured: week 0, 26 and 52
Change From Baseline in Detemir Specific Antibodies
Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Measured: Week 0, week 52
Change From Baseline in Total Antibodies
Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Basophilis)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: week 0, week 52
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Monocytes)
Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.
Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
(ALAT = alanine aminotransferase)
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.
(ALP = alkaline phosphatase)
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Measured: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory
Measured: Week 0, week 52
Adverse Events
Measured: Weeks 0-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447382
- Sponsor's protocol ID
- EX1729-1778
- Other IDs
- 2006-004733-15
- Status last verified
- Dec 2023
- First submitted
- 13 Mar 2007
- Last updated
- 2 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bolus Regimen With Insulin Aspart as the Bolus Insulin
- ClinicalTrials.gov ID
- NCT00447382
- Acronym / sponsor ID
- EX1729-1778
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Posted 12 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NN304 | Active comparator | Drug: insulin detemir, Drug: insulin aspartIndividually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks |
| NN729 | Experimental | Drug: insulin aspart, Drug: insulin detemirIndividually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes for at least 12 months
- Basal-bolus treatment for at least 3 months
- Body Mass Index (BMI) less than or equal to 35.0 kg/m^2
- HbA1c (glycosylated haemoglobin) less than or equal to 12.0%
Key exclusion criteria (5 listed)
- Known or suspected allergy to trial products or related products
- Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
- Receipt of any trial drug within 1 month prior to this trial
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
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 detemirNN304 injected s.c. (under the skin). Given as basal insulin. | Drug | NN304 |
| insulin aspartInjected s.c. (under the skin). Given as bolus insulin. | Drug | NN304, NN729 |
| insulin detemirNN729 injected s.c. (under the skin). Given as basal insulin | Drug | NN729 |
Primary outcome
Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
Time frame: week 0, week 52
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
23 secondary outcomes
Hypoglycaemic Episodes
Time frame: Weeks 0-52
Glycaemic Control Parameters (Change in HbA1c)
Time frame: week 0, week 52
Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
Time frame: week 0, week 52
Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
Time frame: week 0, 26 and 52
Change From Baseline in Detemir Specific Antibodies
Time frame: Week 0, week 52
Change From Baseline in Total Antibodies
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Basophilis)
Time frame: week 0, week 52
Clinical Laboratory Values (Change in Haematology - Eosinophils)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Haemoglobin)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Lymphocytes)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Monocytes)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Neutrophils)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Thrombocytes)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Haematology - Leucocytes)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Albumin)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Creatinine)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Potassium)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Sodium)
Time frame: Week 0, week 52
Clinical Laboratory Values (Change in Biochemistry - Total Protein)
Time frame: Week 0, week 52
Adverse Events
Time frame: Weeks 0-52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- 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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 5 sites in 5 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 4 inclusion and 5 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, North Macedonia, Russia, Serbia and Montenegro, South Africa. 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 12 May 2011). 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 From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies (time frame: week 0, week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.