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Study 2 of 2431 for search of: | received on or after 11/14/2008 |
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Descriptive Information Fields | |||||
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Brief Title † | Comparison of the Change in Fat Distribution in Overweight and Obese Type 2 Diabetics After Insulin Treatment | ||||
Official Title † | Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes Mellitus After 26 Weeks of Treatment With Insulin Detemir Versus Insulin NPH Both Combined With Insulin Aspart | ||||
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 (both combined with insulin aspart in the main meals) in overweight and obese type 2 diabetics. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | to compare the change in trunk fat mass assessed by DEXA [ Time Frame: at baseline and 26 weeks of treatment. ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | additional for DEXA: Whole Body Fat Mass (g), Whole Body Lean Mass (g), Trunk Lean Mass (g), Calculated Whole Body Fat Percentage and Calculated Trunk Fat Percentage [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] cT scan: Visceral Adipose Tissue Area (cm2), Subcutaneous Adipose Tissue Area (cm2), Calculated Visceral/Subcutaneous Adipose Tissue Ratio and Liver/Spleen Attenuation Ratio (L/S) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] change in HbA1c [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] change in Fasting Plasma Glucose (FPG) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] to quantify the relationship between BMI and required daily dose of insulin detemir [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] to quantify the cytokine in the adipose tissue (adiponectin) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] incidence of hypoglycaemia [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ] lipid profile [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] incidence of Adverse events during the trial [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ] safety profile as measured by laboratory safety parameters [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: Yes ] weight and waist/hip circumference [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] to quantify the inflammatory parameters (hsCRP and PAI-1) [ Time Frame: at baseline and 26 weeks of treatment ] [ Designated as safety issue: No ] |
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Condition † | Diabetes Mellitus, Type 2 | ||||
Intervention † | Drug: insulin detemir Drug: insulin NPH |
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MEDLINE PMIDs | |||||
Links | Clinical Trials at Novo Nordisk  | ||||
Recruitment Information Fields | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 58 | ||||
Start Date † | December 2008 | ||||
Completion Date | December 2009 | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Spain | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00795600 | ||||
Organization ID | NN304-3614 | ||||
Secondary IDs †† | EudraCT No: 2008-003739-19 | ||||
Study Sponsor † | Novo Nordisk | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novo Nordisk | ||||
Verification Date | November 2008 | ||||
First Received Date † | November 20, 2008 | ||||
Last Updated Date | November 21, 2008 |