Phase 4
N=60
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment
Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00795600 ↗Enrolled (actual)
60
Serious AEs
10.2%
Results posted
Jun 2013
Primary outcome: Primary: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) — 0.366; 1.011 percent change — p=0.849
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- insulin detemir (Drug); insulin NPH (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) |
0.535; 1.126 | 0.948 |
| PRIMARY Absolute Change in Trunk Fat Mass |
153.38; 39.43 | 0.710 |
| SECONDARY Absolute Change in Whole Body Fat Mass |
1147.1; 858.88 | 0.709 |
| SECONDARY Percentage Change in Whole Body Fat Mass |
3.870; 4.047 | 0.948 |
| SECONDARY Absolute Change in Whole Body Lean Mass |
-54.20; 1097.2 | 0.162 |
| SECONDARY Percentage Change in Whole Body Lean Mass |
0.051; 2.798 | 0.131 |
| SECONDARY Absolute Change in Trunk Lean Mass |
359.43; 469.84 | 0.766 |
| SECONDARY Percentage Change in Trunk Lean Mass |
1.480; 2.090 | 0.716 |
| SECONDARY Absolute Change in Calculated Whole Body Fat Percentage |
0.782; 0.291 | 0.483 |
| SECONDARY Percentual Change in Calculated Whole Body Fat Percentage |
1.607; 1.491 | 0.952 |
| SECONDARY Absolute Change in Calculated Trunk Fat Percentage |
-0.600; -0.321 | 0.711 |
| SECONDARY Percentual Change in Calculated Trunk Fat Percentage |
-1.543; 0.042 | 0.397 |
| SECONDARY Absolute Change in Visceral Adipose Tissue Area |
-3.258; 5.658 | 0.421 |
| SECONDARY Percentage Change in Visceral Adipose Tissue Area |
-0.535; 4.526 | 0.420 |
| SECONDARY Absolute Change in Subcutaneous Adipose Tissue Area |
7.654; 12.616 | 0.705 |
| SECONDARY Percentage Change in Subcutaneous Adipose Tissue Area |
1.153; 5.743 | 0.341 |
| SECONDARY Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio |
-0.032; -0.036 | 0.902 |
| SECONDARY Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio |
-4.092; -3.303 | 0.839 |
| SECONDARY Absolute Change in Liver/Spleen Attenuation Ratio |
-0.044; -0.023 | 0.607 |
| SECONDARY Percentage Change in Liver/Spleen Attenuation Ratio |
-2.632; -0.855 | 0.635 |
| SECONDARY Absolute Change in HbA1c (Glycosylated Haemoglobin) |
-0.922; -0.792 | 0.628 |
| SECONDARY Absolute Change in Fasting Plasma Glucose (FPG) |
-48.29; -37.36 | 0.535 |
| SECONDARY Absolute Change in Adiponectin |
0.926; 2.844 | 0.660 |
| SECONDARY Absolute Change in Total Cholesterol |
-8.96; 7.77 | — |
| SECONDARY Absolute Change in High Density Lipoprotein (HDL) Cholesterol |
-0.95; 2.87 | — |
| SECONDARY Absolute Change in Low Density Lipoprotein (LDL) Cholesterol |
2.39; 6.14 | — |
| SECONDARY Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol |
1.05; 1.54 | — |
| SECONDARY Absolute Change in Triglycerides |
-14.71; -20.97 | — |
| SECONDARY Absolute Change in Free Fatty Acids |
-0.03; -0.05 | — |
| SECONDARY Absolute Change in Haemoglobin |
-0.38; -0.35 | — |
| SECONDARY Absolute Change in Blood Volume (Haematocrit) |
-1.17; -1.06 | — |
| SECONDARY Absolute Change in Thrombocytes |
0.10 | — |
| SECONDARY Absolute Change in Erythrocytes |
4.64; 4.38 | — |
| SECONDARY Absolute Change in Leucocytes |
-0.01; -0.07 | — |
| SECONDARY Absolute Change in Lymphocytes |
-0.10 | — |
| SECONDARY Absolute Change in Monocytes |
0.10 | — |
| SECONDARY Absolute Change in Neutrophils |
-0.29; 0.01 | — |
| SECONDARY Absolute Change in Eosinophils |
0.01; 0.01 | — |
| SECONDARY Absolute Change in Basophils |
0.00; -0.01 | — |
| SECONDARY Absolute Change in Creatinine |
0.03; -0.00 | — |
| SECONDARY Absolute Change in Creatine Phosphokinase |
-19.86; 21.56 | — |
| SECONDARY Absolute Change in Urea |
2.45; 0.50 | — |
| SECONDARY Absolute Change in Albumin |
-0.02; 0.01 | — |
| SECONDARY Absolute Change in Bilirubin Total |
-0.07; -0.07 | — |
| SECONDARY Absolute Change in Alanine Aminotransferase (ALAT) |
-3.59; -4.55 | — |
| SECONDARY Absolute Change in Aspartate Aminotransferase (ASAT) |
0.23; -0.48 | — |
| SECONDARY Absolute Change in Alkaline Phosphatase |
-7.10; -12.55 | — |
| SECONDARY Absolute Change in Sodium |
1.12; 0.69 | — |
| SECONDARY Absolute Change in Potassium |
-0.20; 0.21 | — |
| SECONDARY Absolute Change in Body Weight |
1.663; 2.293 | 0.518 |
| SECONDARY Absolute Change in Waist Circumference |
0.064; 0.609 | 0.673 |
| SECONDARY Absolute Change in Hip Circumference |
0.577; 0.112 | 0.738 |
| SECONDARY Absolute Change in hsCRP (Highly Sensitive C Reactive Protein) |
1.200; -0.862 | 0.346 |
| SECONDARY Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1) |
-10.77; -12.50 | 0.781 |
| SECONDARY Number of Hypoglycaemic Episodes |
17; 32 | — |
| SECONDARY Number of Non-serious Adverse Events |
64; 103 | — |
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
Data sourced from ClinicalTrials.gov (NCT00795600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.