Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine

This study has been terminated.
Sponsor:
Collaborators:
Medical University of Vienna
University of Bern
CenTrial GmbH
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00656422
First received: April 4, 2008
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.


Condition Intervention Phase
Diabetes
Obesity
Drug: insulin Levemir
Drug: insulin Lantus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • To describe changes in hepatic fat content between groups. [ Time Frame: week 26, week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the weight changes from baseline to month 12 between the groups following a subcutaneous treatment strategy with either insulin detemir or insulin glargine. [ Time Frame: week 26, week 52 ] [ Designated as safety issue: Yes ]
  • To evaluate changes in body fat and visceral adipose tissue between groups. [ Time Frame: week 26, week 52 ] [ Designated as safety issue: No ]
  • To describe changes in waist and hip circumferences between groups. [ Time Frame: weel 26, week 52 ] [ Designated as safety issue: No ]
  • To describe changes in eating behavior and food selection between groups. [ Time Frame: week 26, week 52 ] [ Designated as safety issue: No ]
  • To describe changes in well being and disease perception between groups. [ Time Frame: week 26, week 52 ] [ Designated as safety issue: No ]
  • To evaluate the daily insulin dose between groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To describe the fasting blood glucose between groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate hypoglycaemia between groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To evaluate safety between groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: November 2007
Arms Assigned Interventions
Experimental: insulin Levemir Drug: insulin Levemir
The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.
Experimental: insulin Lantus Drug: insulin Lantus
The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years and < 80 years
  • Gender: female, male
  • Type 2 diabetes
  • BMI: 20.0 - 38.0
  • Anti-GAD antibody negative
  • Fasting blood glucose > 126 mg/dl
  • HbA1c 7.0 - 11.0%
  • Need for insulin therapy

Exclusion Criteria:

  • Previous therapy with insulin within the last 3 months prior to inclusion into the study
  • Previous therapy with glitazones within the last 6 months prior to inclusion into the study
  • Change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed)
  • Concomitant participation in other clinical trials
  • Type 1 diabetes
  • Cardiac and macrovascular disease
  • Malignancy including leukaemia and lymphoma within the last 5 years
  • Liver disease: cirrhosis or chronic active hepatitis, except fat liver
  • Significant renal dysfunction
  • other Endocrine disease
  • significant laboratory abnormalities
  • History of active substance abuse (including an average alcohol consume of > 40g/day and drugs) within the past 2 years
  • Female patients: Pregnancy or childbearing potential without adequate contraception (for male patients contraception is not considered as medically important)
  • Present therapy with systemic steroids
  • Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
  • Use of anti-obesity drugs 3 months prior or during the trial
  • Potentially unreliable subjects, probably non compliant subjects, and those judged by the investigator to be unsuitable for the study
  • Contraindications for MRI scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
  • Known hypersensitivity to insulin detemir, insulin glargine or to any of the other components
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656422

Locations
Austria
University Hospital Graz
Graz, Austria, 8036
Medical University Graz
Graz, Austria, 8036
Medical University Vienna
Vienna, Austria, 1090
Germany
University Hospital of Tübingen
Tübingen, Germany, 72076
Switzerland
University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Tuebingen
Medical University of Vienna
University of Bern
CenTrial GmbH
Investigators
Principal Investigator: Andreas Fritsche, Prof. Dr. University Hospital of Tübingen
Principal Investigator: Hermann Toplak, Prof. Dr. University Hospital Graz
Study Chair: Peter Diem, Prof. Dr. Bern University Hospital
Study Chair: Alexandra Kautzky-Willer, Prof. Dr. Medical University Vienna
Principal Investigator: Thomas Pieber, Univ. Prof. Dr. Medical University of Graz
  More Information

No publications provided

Responsible Party: University Hospital of Tübingen, Medical Department
ClinicalTrials.gov Identifier: NCT00656422     History of Changes
Other Study ID Numbers: N-ISP-1, LEV-002
Study First Received: April 4, 2008
Last Updated: October 31, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Tuebingen:
insulin therapy
hepatic fat
type 2 diabetes
body composition
comparison of insulin detemir and insulin glargine
Changes in Hepatic Fat
Obesity

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

ClinicalTrials.gov processed this record on July 29, 2014