Clinical trial NCT00795600: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)
timeFrame: week 0, week 26
measure: Absolute Change in Trunk Fat Mass
timeFrame: week 0, week 26
Secondary outcomes:
measure: Absolute Change in Whole Body Fat Mass
timeFrame: Week 0, week 26
measure: Percentage Change in Whole Body Fat Mass
timeFrame: Week 0, week 26
measure: Absolute Change in Whole Body Lean Mass
timeFrame: Week 0, week 26
measure: Percentage Change in Whole Body Lean Mass
timeFrame: Week 0, week 26
measure: Absolute Change in Trunk Lean Mass
timeFrame: Week 0, week 26
measure: Percentage Change in Trunk Lean Mass
timeFrame: Week 0, week 26
measure: Absolute Change in Calculated Whole Body Fat Percentage
timeFrame: Week 0, week 26
measure: Percentual Change in Calculated Whole Body Fat Percentage
timeFrame: Week 0, week 26
measure: Absolute Change in Calculated Trunk Fat Percentage
timeFrame: Week 0, week 26
measure: Percentual Change in Calculated Trunk Fat Percentage
timeFrame: Week 0, week 26
measure: Absolute Change in Visceral Adipose Tissue Area
timeFrame: Week 0, week 26
measure: Percentage Change in Visceral Adipose Tissue Area
timeFrame: Week 0, week 26
measure: Absolute Change in Subcutaneous Adipose Tissue Area
timeFrame: Week 0, week 26
measure: Percentage Change in Subcutaneous Adipose Tissue Area
timeFrame: Week 0, week 26
measure: Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
timeFrame: Week 0, week 26
measure: Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio
timeFrame: Week 0, week 26
measure: Absolute Change in Liver/Spleen Attenuation Ratio
timeFrame: Week 0, week 26
measure: Percentage Change in Liver/Spleen Attenuation Ratio
timeFrame: Week 0, week 26
measure: Absolute Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 26
measure: Absolute Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 26
measure: Absolute Change in Adiponectin
timeFrame: Week 0, week 26
measure: Absolute Change in Total Cholesterol
timeFrame: Week 0, week 26
measure: Absolute Change in High Density Lipoprotein (HDL) Cholesterol
timeFrame: Week 0, week 26
measure: Absolute Change in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Week 0, week 26
measure: Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: Week 0, week 26
measure: Absolute Change in Triglycerides
timeFrame: Week 0, week 26
measure: Absolute Change in Free Fatty Acids
timeFrame: Week 0, week 26
measure: Absolute Change in Haemoglobin
timeFrame: Week 0, week 26
measure: Absolute Change in Blood Volume (Haematocrit)
timeFrame: Week 0, week 26
measure: Absolute Change in Thrombocytes
timeFrame: Week 0, week 26
measure: Absolute Change in Erythrocytes
timeFrame: Week 0, week 26
measure: Absolute Change in Leucocytes
timeFrame: Week 0, week 26
measure: Absolute Change in Lymphocytes
timeFrame: Week 0, week 26
measure: Absolute Change in Monocytes
timeFrame: Week 0, week 26
measure: Absolute Change in Neutrophils
timeFrame: Week 0, week 26
measure: Absolute Change in Eosinophils
timeFrame: Week 0, week 26
measure: Absolute Change in Basophils
timeFrame: Week 0, week 26
measure: Absolute Change in Creatinine
timeFrame: Week 0, week 26
measure: Absolute Change in Creatine Phosphokinase
timeFrame: Week 0, week 26
measure: Absolute Change in Urea
timeFrame: Week 0, week 26
measure: Absolute Change in Albumin
timeFrame: Week 0, week 26
measure: Absolute Change in Bilirubin Total
timeFrame: Week 0, week 26
measure: Absolute Change in Alanine Aminotransferase (ALAT)
timeFrame: Week 0, week 26
measure: Absolute Change in Aspartate Aminotransferase (ASAT)
timeFrame: Week 0, week 26
measure: Absolute Change in Alkaline Phosphatase
timeFrame: Week 0, week 26
measure: Absolute Change in Sodium
timeFrame: Week 0, week 26
measure: Absolute Change in Potassium
timeFrame: Week 0, week 26
measure: Absolute Change in Body Weight
timeFrame: Week 0, week 26
measure: Absolute Change in Waist Circumference
timeFrame: Week 0, week 26
measure: Absolute Change in Hip Circumference
timeFrame: Week 0, week 26
measure: Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)
timeFrame: Week 0, week 26
measure: Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)
timeFrame: Week 0, week 26
measure: Number of Hypoglycaemic Episodes
timeFrame: Weeks 0-26
measure: Number of Non-serious Adverse Events
timeFrame: Weeks 0-26
Other outcomes:
Locations:
city: Málaga
country: Spain
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.