DiabetesPhase 43LNCT00506662
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
A Phase 4 study testing insulin detemir and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir and insulin NPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2007to Dec 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 diabetes
- Insulin naive
- Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
- HbA1c between 8% - 10.5%
Who cannot join
- Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
- Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
- Proliferative retinopathy, maculopathy requiring treatment,
- Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
- End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
- Acute disease with poor prognosis
Show all 16Show fewer
- History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator
- Legal incapacity or limited legal capacity (patients under guardianship or curatorship)
- Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment)
- Participation in another clinical trial less than one month before inclusion in this trial
- Illness requiring repeated hospitalisation
- Known or suspected allergy to the insulin or any compositional component
- Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
- Terminal illness
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.
This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.
Read the detailed description
Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, insulin NPH
- 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, s.c. (under the skin) injection, once daily
insulin NPHDrug
Treat-to-target, s.c. (under the skin) injection, once daily
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Experimental | Individually adjusted dose of insulin detemir once daily Receives: Drug: insulin detemir |
| Insulin NPH | Active comparator | Individually adjusted dose of insulin NPH once daily Receives: Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c) at Month 7
Measured: week 0, month 7
Secondary outcomes (12)
Change in Glycosylated Haemoglobin (HbA1c) at Month 4
Measured: week 0, month 4
Change in Mean Fasting Plasma Glucose (FPG) at Month 7
Measured: week 0, month 7
Change in Mean Fasting Plasma Glucose (FPG) at Month 4
Measured: week 0, month 4
Change in Mean Pre-lunch Plasma Glucose at Month 7
Measured: week 0, month 7
Change in Mean Pre-lunch Plasma Glucose at Month 4
Measured: week 0, month 4
Change in Mean Pre-dinner Plasma Glucose at Month 7
Measured: week 0, month 7
Change in Mean Pre-dinner Plasma Glucose at Month 4
Measured: week 0, month 4
Change in Body Weight at Month 7
Measured: week 0, month 7
Change in Body Weight at Month 4
Measured: week 0, month 4
Mean Number of Total Hypoglycaemic Episodes, Month 1
Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.
Measured: weeks -2-0, month 1
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.
Measured: weeks -2-0, months 2-4
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period.
Measured: weeks -2-0, months 5-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: See termination reason in detailed description
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
- 86 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
- NCT00506662
- Sponsor's protocol ID
- NN304-1808
- Other IDs
- 2006-006589-41
- Acronym
- 3L
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2007
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00506662
- Acronym / sponsor ID
- 3L / NN304-1808
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 17 Nov 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. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.
Detailed description
Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | Experimental | Drug: insulin detemirIndividually adjusted dose of insulin detemir once daily |
| Insulin NPH | Active comparator | Drug: insulin NPHIndividually adjusted dose of insulin NPH once daily |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Insulin naive
- Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets
- HbA1c between 8% - 10.5%
Key exclusion criteria (16 listed)
- Secondary diabetes, MODY (Maturity Onset Diabetes of the Young)
- Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator)
- Proliferative retinopathy, maculopathy requiring treatment,
- Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia
- End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
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, s.c. (under the skin) injection, once daily | Drug | Insulin detemir |
| insulin NPHTreat-to-target, s.c. (under the skin) injection, once daily | Drug | Insulin NPH |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c) at Month 7
Time frame: week 0, month 7
12 secondary outcomes
Change in Glycosylated Haemoglobin (HbA1c) at Month 4
Time frame: week 0, month 4
Change in Mean Fasting Plasma Glucose (FPG) at Month 7
Time frame: week 0, month 7
Change in Mean Fasting Plasma Glucose (FPG) at Month 4
Time frame: week 0, month 4
Change in Mean Pre-lunch Plasma Glucose at Month 7
Time frame: week 0, month 7
Change in Mean Pre-lunch Plasma Glucose at Month 4
Time frame: week 0, month 4
Change in Mean Pre-dinner Plasma Glucose at Month 7
Time frame: week 0, month 7
Change in Mean Pre-dinner Plasma Glucose at Month 4
Time frame: week 0, month 4
Change in Body Weight at Month 7
Time frame: week 0, month 7
Change in Body Weight at Month 4
Time frame: week 0, month 4
Mean Number of Total Hypoglycaemic Episodes, Month 1
Time frame: weeks -2-0, month 1
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Time frame: weeks -2-0, months 2-4
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Time frame: weeks -2-0, months 5-7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- 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
2 sites in 2 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 NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in 2 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 16 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: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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 17 Nov 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?
Change in Glycosylated Haemoglobin (HbA1c) at Month 7 (time frame: week 0, month 7). 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 NCT00506662, 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 14 Aug 2023.