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Comparison of the Change in Fat Distribution in Overweight and Obese Type 2 Diabetics After Insulin Treatment.

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00795600
First received: November 20, 2008
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin NPH
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: insulin detemir
Insulin detemir once daily plus insulin aspart at mealtime
Other Names:
  • NN304
  • Levemir®
Active Comparator: B Drug: insulin NPH
Insulin NPH once daily plus insulin aspart at mealtime
Other Name: Insulatard®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • HbA1c between 7.0 - 11.0 %
  • BMI between 27.5kg/m2 - 40 kg/m2

Exclusion Criteria:

  • Treatment with any OAD (Oral Antidiabetic Drugs) 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, 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 NYHA class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795600

Locations
Spain
Málaga, Spain, 29009
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Fernando Fuentes, PhD Novo Nordisk Pharma SA
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00795600     History of Changes
Other Study ID Numbers: NN304-3614, 2008-003739-19
Study First Received: November 20, 2008
Last Updated: March 8, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
 Insulin aspart
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013