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Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes (4T)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: Proliferative retinopathy Recurrent major hypoglycaemia Cardial problems Uncontrolled hypertension Impaired hepatic or renal function

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Insulin detemir (basal insulin)

Insulin aspart (prandial insulin)

Biphasic insulin aspart 30 (biphasic insulin)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

HbA1c (Glycosylated Haemoglobin) at Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
HbA1c (Glycosylated Haemoglobin) at Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.

Secondary Outcome Measures

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.
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
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%.
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%.
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.
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.
Change From Baseline in Body Weight at Month 12
Change From Baseline in Body Weight at 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.
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.
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.
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.
Number of Participants Having an 'Other' Adverse Event

Full Information

First Posted
September 13, 2005
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00184600
Brief Title
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
Acronym
4T
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin detemir (basal insulin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin aspart (prandial insulin)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Biphasic insulin aspart 30 (biphasic insulin)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Description
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
Primary Outcome Measure Information:
Title
HbA1c (Glycosylated Haemoglobin) at Month 12
Description
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time Frame
Baseline, Month 12
Title
HbA1c (Glycosylated Haemoglobin) at Month 36
Description
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time Frame
Baseline, Month 36
Secondary Outcome Measure Information:
Title
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%
Description
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.
Time Frame
Month 12
Title
Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
Description
Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36
Time Frame
Month 36
Title
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%
Description
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%.
Time Frame
Month 12
Title
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%
Description
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%.
Time Frame
Month 36
Title
Percentage of Participants Who Required A Second Insulin Therapy by Month 12
Description
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.
Time Frame
Month 12
Title
Percentage of Participants Who Required A Second Insulin Therapy by Month 36
Description
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.
Time Frame
Month 36
Title
Change From Baseline in Body Weight at Month 12
Time Frame
Week 0 (baseline), month 12
Title
Change From Baseline in Body Weight at Month 36
Time Frame
Week 0 (baseline), month 36
Title
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months
Description
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.
Time Frame
Baseline, month 12
Title
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months
Description
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.
Time Frame
Baseline, month 36
Title
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months
Description
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.
Time Frame
Month 12
Title
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months
Description
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.
Time Frame
Month 36
Title
Number of Participants Having an 'Other' Adverse Event
Time Frame
Up to month 37 (36 months of treatment plus 1 month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Proliferative retinopathy Recurrent major hypoglycaemia Cardial problems Uncontrolled hypertension Impaired hepatic or renal function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 15
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Galway
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Aberdeen
ZIP/Postal Code
AB25 1LD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Addlestone
ZIP/Postal Code
KT15 2BH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Airdrie
ZIP/Postal Code
ML6 0JS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ashton-Under-Lyne
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Ayr
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT37 9RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT9 78B
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Berkshire
ZIP/Postal Code
RG7 3SQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bury St Edmunds
ZIP/Postal Code
IP30 9QU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Coventry
ZIP/Postal Code
CV1 4FH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Crawley
ZIP/Postal Code
RH10 7DH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Derby
ZIP/Postal Code
DE22 3DT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5AX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Haywards Heath
ZIP/Postal Code
RH16 4EX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Headington
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
High Wycombe
ZIP/Postal Code
HP11 2TZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Kettering
ZIP/Postal Code
NN16 8UZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Livingstone
ZIP/Postal Code
EH54 6PP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
N19 3UA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 0JE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M41 5SL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Middlesborough
ZIP/Postal Code
TS3 4BW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE29 0LR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
ZIP/Postal Code
NR4 7UZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Plymouth
ZIP/Postal Code
PL8 8DQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Rugby
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Skipton
ZIP/Postal Code
BD23 1EU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Welwyn Garden City
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Whiston
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19850703
Citation
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. Erratum In: N Engl J Med. 2010 Nov 18;363(21):2078.
Results Reference
result
PubMed Identifier
17890232
Citation
Holman 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 Reference
result
PubMed Identifier
21480965
Citation
Jenkins 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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

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