DiabetesPhase 34TNCT00184600
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
A Phase 3 study testing biphasic insulin aspart, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 63 sites in 2 countries.
Trial summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify… 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 detemir and insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 63 sitesin 2 countries
- Study dates
- Nov 2004to Aug 2009
- 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 2 diabetes
- Insulin naive
- On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
- HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
Who cannot join
- Proliferative retinopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United Kingdom59 sites
Novo Nordisk Investigational Site
Aberdeen, AB25 1LD
Novo Nordisk Investigational Site
Addlestone, KT15 2BH
Novo Nordisk Investigational Site
Airdrie, ML6 0JS
Novo Nordisk Investigational Site
Ashton-under-Lyne, OL6 9RW
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Belfast, BT12 6BA
Novo Nordisk Investigational Site
Belfast, BT37 9RH
Novo Nordisk Investigational Site
Belfast, BT9 78B
Novo Nordisk Investigational Site
Berkshire, RG7 3SQ
Novo Nordisk Investigational Site
Birmingham, B71 4HJ
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Bournemouth, BH7 7DW
Novo Nordisk Investigational Site
Bradford, BD9 6RJ
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Bury St Edmunds, IP30 9QU
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ
Novo Nordisk Investigational Site
Colchester, CO4 5JL
Novo Nordisk Investigational Site
Coventry, CV1 4FH
Novo Nordisk Investigational Site
Crawley, RH10 7DH
Novo Nordisk Investigational Site
Derby, DE22 3DT
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Exeter, EX2 5AX
Novo Nordisk Investigational Site
Gillingham, ME7 5NY
Novo Nordisk Investigational Site
Glasgow, G4 0SF
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Haywards Heath, RH16 4EX
Novo Nordisk Investigational Site
Headington, OX3 7LE
Novo Nordisk Investigational Site
High Wycombe, HP11 2TZ
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Kettering, NN16 8UZ
Novo Nordisk Investigational Site
Leeds, LS9 7TF
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
Leicester, LE5 4PW
Novo Nordisk Investigational Site
Liverpool, L7 8XP
Novo Nordisk Investigational Site
Liverpool, L9 7AL
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
London, N19 3UA
Novo Nordisk Investigational Site
London, SE5 9RS
Novo Nordisk Investigational Site
London
Novo Nordisk Investigational Site
Manchester, M13 0JE
Novo Nordisk Investigational Site
Manchester, M23 9LT
Novo Nordisk Investigational Site
Manchester, M41 5SL
Novo Nordisk Investigational Site
Manchester, M8 5RB
Novo Nordisk Investigational Site
Middlesbrough, TS3 4BW
Novo Nordisk Investigational Site
Newcastle, NE29 0LR
Novo Nordisk Investigational Site
Newcastle, NE4 6BE
Novo Nordisk Investigational Site
Norfolk, NR4 7UZ
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Rugby, CV22 5PX
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Skipton, BD23 1EU
Novo Nordisk Investigational Site
Stevenage, SG1 4AB
Novo Nordisk Investigational Site
Torquay, TQ2 7AA
Novo Nordisk Investigational Site
Welwyn Garden City, AL7 4HQ
Novo Nordisk Investigational Site
Whiston, L35 5DR
Novo Nordisk Investigational Site
Wirral, Merseyside, CH63 4JY
Ireland4 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 15
Novo Nordisk Investigational Site
Dublin, DUBLIN 7
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Galway
About this study
Official title: A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart, 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.
biphasic insulin aspartDrug
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
insulin detemirDrug
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
insulin aspartDrug
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir (basal insulin) | Experimental | Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen. Receives: Drug: insulin detemir |
| Insulin aspart (prandial insulin) | Active comparator | Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen. Receives: Drug: biphasic insulin aspart |
| Biphasic insulin aspart 30 (biphasic insulin) | Active comparator | Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen. Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (Glycosylated Haemoglobin) at Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Measured: Baseline, Month 12
HbA1c (Glycosylated Haemoglobin) at Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Measured: Baseline, Month 36
Secondary outcomes (13)
Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.
Measured: Month 12
Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36
Measured: Month 36
Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.
Measured: Month 12
Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.
Measured: Month 36
Percentage of Participants Who Required A Second Insulin Therapy by Month 12
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.
Measured: Month 12
Percentage of Participants Who Required A Second Insulin Therapy by Month 36
Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.
Measured: Month 36
Change From Baseline in Body Weight at Month 12
Measured: Week 0 (baseline), month 12
Change From Baseline in Body Weight at Month 36
Measured: Week 0 (baseline), month 36
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.
Measured: Baseline, month 12
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.
Measured: Baseline, month 36
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.
Measured: Month 12
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.
Measured: Month 36
Number of Participants Having an 'Other' Adverse Event
Measured: Up to month 37 (36 months of treatment plus 1 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2009
- Study completionAug 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 (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 708 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
- NCT00184600
- Sponsor's protocol ID
- NN304-1613
- Other IDs
- 2004-000514-38, 2004
- Acronym
- 4T
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22.
PubMed 19850703Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007 Oct 25;357(17):1716-30. doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.
PubMed 17890232Jenkins N, Hallowell N, Farmer AJ, Holman RR, Lawton J. Participants' experiences of intensifying insulin therapy during the Treating to Target in Type 2 Diabetes (4-T) trial: qualitative interview study. Diabet Med. 2011 May;28(5):543-8. doi: 10.1111/j.1464-5491.2010.03200.x.
PubMed 21480965
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability
- ClinicalTrials.gov ID
- NCT00184600
- Acronym / sponsor ID
- 4T / NN304-1613
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 25 Jul 2011
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 this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir (basal insulin) | Experimental | Drug: insulin detemirIndividually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen. |
| Insulin aspart (prandial insulin) | Active comparator | Drug: biphasic insulin aspartIndividually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen. |
| Biphasic insulin aspart 30 (biphasic insulin) | Active comparator | Drug: insulin aspartIndividually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen. |
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
- Insulin naive
- On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
- HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
Key exclusion criteria (5 listed)
- Proliferative retinopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
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 (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart | Drug | Insulin aspart (prandial insulin) |
| insulin detemirTreat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart | Drug | Insulin detemir (basal insulin) |
| insulin aspartTreat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir | Drug | Biphasic insulin aspart 30 (biphasic insulin) |
Primary outcome
HbA1c (Glycosylated Haemoglobin) at Month 12
Time frame: Baseline, Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
HbA1c (Glycosylated Haemoglobin) at Month 36
Time frame: Baseline, Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
13 secondary outcomes
Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
Time frame: Month 12
Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
Time frame: Month 36
Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Time frame: Month 12
Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Time frame: Month 36
Percentage of Participants Who Required A Second Insulin Therapy by Month 12
Time frame: Month 12
Percentage of Participants Who Required A Second Insulin Therapy by Month 36
Time frame: Month 36
Change From Baseline in Body Weight at Month 12
Time frame: Week 0 (baseline), month 12
Change From Baseline in Body Weight at Month 36
Time frame: Week 0 (baseline), month 36
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
Time frame: Baseline, month 12
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
Time frame: Baseline, month 36
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
Time frame: Month 12
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
Time frame: Month 36
Number of Participants Having an 'Other' Adverse Event
Time frame: Up to month 37 (36 months of treatment plus 1 month follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19850703Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22.
- Results publication: PubMed 17890232Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007 Oct 25;357(17):1716-30. doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.
- Results publication: PubMed 21480965Jenkins N, Hallowell N, Farmer AJ, Holman RR, Lawton J. Participants' experiences of intensifying insulin therapy during the Treating to Target in Type 2 Diabetes (4-T) trial: qualitative interview study. Diabet Med. 2011 May;28(5):543-8. doi: 10.1111/j.1464-5491.2010.03200.x.
- 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
63 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biphasic insulin aspart, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 63 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 5 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 9 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 63 sites in United Kingdom, Ireland. 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 25 Jul 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?
HbA1c (Glycosylated Haemoglobin) at Month 12 (time frame: Baseline, Month 12). 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 NCT00184600, which also lists 3 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 9 Mar 2017.