Back to resultsComparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
- Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
- Body Mass Index (BMI) between 27.5-40 kg/m^2
Exclusion Criteria:
- Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
- Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
- Previous or planned surgical treatment of obesity
- Total daily insulin dose higher or equal 2 IU/kg
- Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
- Receipt of any investigational drug within 1 month prior to this trial
- Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
insulin detemir
insulin NPH
Arm Description
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Outcomes
Primary Outcome Measures
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Absolute Change in Trunk Fat Mass
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Secondary Outcome Measures
Absolute Change in Whole Body Fat Mass
Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Percentage Change in Whole Body Fat Mass
Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.
Absolute Change in Whole Body Lean Mass
Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.
Percentage Change in Whole Body Lean Mass
Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.
Absolute Change in Trunk Lean Mass
Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate
Percentage Change in Trunk Lean Mass
Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.
Absolute Change in Calculated Whole Body Fat Percentage
Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate
Percentual Change in Calculated Whole Body Fat Percentage
Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.
Absolute Change in Calculated Trunk Fat Percentage
Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate
Percentual Change in Calculated Trunk Fat Percentage
Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.
Absolute Change in Visceral Adipose Tissue Area
Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate
Percentage Change in Visceral Adipose Tissue Area
Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.
Absolute Change in Subcutaneous Adipose Tissue Area
Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate
Percentage Change in Subcutaneous Adipose Tissue Area
Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Absolute Change in Liver/Spleen Attenuation Ratio
Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.
Percentage Change in Liver/Spleen Attenuation Ratio
Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.
Absolute Change in HbA1c (Glycosylated Haemoglobin)
Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.
Absolute Change in Fasting Plasma Glucose (FPG)
Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.
Absolute Change in Adiponectin
Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.
Absolute Change in Total Cholesterol
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Absolute Change in Triglycerides
Absolute Change in Free Fatty Acids
Absolute Change in Haemoglobin
Absolute Change in Blood Volume (Haematocrit)
Absolute Change in Thrombocytes
Absolute Change in Erythrocytes
Absolute Change in Leucocytes
Absolute Change in Lymphocytes
Absolute Change in Monocytes
Absolute Change in Neutrophils
Absolute Change in Eosinophils
Absolute Change in Basophils
Absolute Change in Creatinine
Absolute Change in Creatine Phosphokinase
Absolute Change in Urea
Absolute Change in Albumin
Absolute Change in Bilirubin Total
Absolute Change in Alanine Aminotransferase (ALAT)
Absolute Change in Aspartate Aminotransferase (ASAT)
Absolute Change in Alkaline Phosphatase
Absolute Change in Sodium
Absolute Change in Potassium
Absolute Change in Body Weight
Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.
Absolute Change in Waist Circumference
Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.
Absolute Change in Hip Circumference
Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.
Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
Number of Hypoglycaemic Episodes
Number of episodes reported during the trial.
Number of Non-serious Adverse Events
Number of episodes reported during the trial.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795600
Brief Title
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Official Title
A Multi-centre, Open-labelled, Randomised, Two-group Parallel Trial Comparing the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After 26 Weeks of Treatment With Insulin Detemir Once Daily Versus Insulin NPH Once Daily, Both With Insulin Aspart at Mealtimes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (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 clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insulin detemir
Arm Type
Experimental
Arm Description
Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Arm Title
insulin NPH
Arm Type
Active Comparator
Arm Description
Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Insulin detemir once daily plus insulin aspart at mealtime
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Insulin NPH once daily plus insulin aspart at mealtime
Primary Outcome Measure Information:
Title
Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
Description
Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.
Time Frame
week 0, week 26
Title
Absolute Change in Trunk Fat Mass
Description
Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Time Frame
week 0, week 26
Secondary Outcome Measure Information:
Title
Absolute Change in Whole Body Fat Mass
Description
Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Percentage Change in Whole Body Fat Mass
Description
Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Whole Body Lean Mass
Description
Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Percentage Change in Whole Body Lean Mass
Description
Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Trunk Lean Mass
Description
Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate
Time Frame
Week 0, week 26
Title
Percentage Change in Trunk Lean Mass
Description
Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Calculated Whole Body Fat Percentage
Description
Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate
Time Frame
Week 0, week 26
Title
Percentual Change in Calculated Whole Body Fat Percentage
Description
Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Calculated Trunk Fat Percentage
Description
Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate
Time Frame
Week 0, week 26
Title
Percentual Change in Calculated Trunk Fat Percentage
Description
Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Visceral Adipose Tissue Area
Description
Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate
Time Frame
Week 0, week 26
Title
Percentage Change in Visceral Adipose Tissue Area
Description
Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Subcutaneous Adipose Tissue Area
Description
Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate
Time Frame
Week 0, week 26
Title
Percentage Change in Subcutaneous Adipose Tissue Area
Description
Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Description
Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
Description
Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Liver/Spleen Attenuation Ratio
Description
Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Percentage Change in Liver/Spleen Attenuation Ratio
Description
Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in HbA1c (Glycosylated Haemoglobin)
Description
Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Fasting Plasma Glucose (FPG)
Description
Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Adiponectin
Description
Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Total Cholesterol
Time Frame
Week 0, week 26
Title
Absolute Change in High Density Lipoprotein (HDL) Cholesterol
Time Frame
Week 0, week 26
Title
Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
Time Frame
Week 0, week 26
Title
Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Time Frame
Week 0, week 26
Title
Absolute Change in Triglycerides
Time Frame
Week 0, week 26
Title
Absolute Change in Free Fatty Acids
Time Frame
Week 0, week 26
Title
Absolute Change in Haemoglobin
Time Frame
Week 0, week 26
Title
Absolute Change in Blood Volume (Haematocrit)
Time Frame
Week 0, week 26
Title
Absolute Change in Thrombocytes
Time Frame
Week 0, week 26
Title
Absolute Change in Erythrocytes
Time Frame
Week 0, week 26
Title
Absolute Change in Leucocytes
Time Frame
Week 0, week 26
Title
Absolute Change in Lymphocytes
Time Frame
Week 0, week 26
Title
Absolute Change in Monocytes
Time Frame
Week 0, week 26
Title
Absolute Change in Neutrophils
Time Frame
Week 0, week 26
Title
Absolute Change in Eosinophils
Time Frame
Week 0, week 26
Title
Absolute Change in Basophils
Time Frame
Week 0, week 26
Title
Absolute Change in Creatinine
Time Frame
Week 0, week 26
Title
Absolute Change in Creatine Phosphokinase
Time Frame
Week 0, week 26
Title
Absolute Change in Urea
Time Frame
Week 0, week 26
Title
Absolute Change in Albumin
Time Frame
Week 0, week 26
Title
Absolute Change in Bilirubin Total
Time Frame
Week 0, week 26
Title
Absolute Change in Alanine Aminotransferase (ALAT)
Time Frame
Week 0, week 26
Title
Absolute Change in Aspartate Aminotransferase (ASAT)
Time Frame
Week 0, week 26
Title
Absolute Change in Alkaline Phosphatase
Time Frame
Week 0, week 26
Title
Absolute Change in Sodium
Time Frame
Week 0, week 26
Title
Absolute Change in Potassium
Time Frame
Week 0, week 26
Title
Absolute Change in Body Weight
Description
Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.
Time Frame
Week 0, week 26
Title
Absolute Change in Waist Circumference
Description
Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in Hip Circumference
Description
Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
Description
Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.
Time Frame
Week 0, week 26
Title
Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
Time Frame
Week 0, week 26
Title
Number of Hypoglycaemic Episodes
Description
Number of episodes reported during the trial.
Time Frame
Weeks 0-26
Title
Number of Non-serious Adverse Events
Description
Number of episodes reported during the trial.
Time Frame
Weeks 0-26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2
Exclusion Criteria:
Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
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:
City
Málaga
ZIP/Postal Code
29009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33166419
Citation
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
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