NCT00656422

Brief Summary

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3 diabetes

Geographic Reach
3 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

First QC Date

April 4, 2008

Last Update Submit

October 31, 2012

Conditions

DiabetesObesity

Keywords

insulin therapyhepatic fattype 2 diabetesbody compositioncomparison of insulin detemir and insulin glargineChanges in Hepatic FatObesity

Outcome Measures

Primary Outcomes (1)

  • To describe changes in hepatic fat content between groups.

    week 26, week 52

Secondary Outcomes (9)

  • 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.

    week 26, week 52

  • To evaluate changes in body fat and visceral adipose tissue between groups.

    week 26, week 52

  • To describe changes in waist and hip circumferences between groups.

    weel 26, week 52

  • To describe changes in eating behavior and food selection between groups.

    week 26, week 52

  • To describe changes in well being and disease perception between groups.

    week 26, week 52

  • +4 more secondary outcomes

Study Arms (2)

insulin Levemir

EXPERIMENTAL
Drug: insulin Levemir

insulin Lantus

EXPERIMENTAL
Drug: insulin Lantus

Interventions

insulin LevemirDRUG

The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.

insulin Levemir
insulin LantusDRUG

The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.

insulin Lantus

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical University Graz

Graz, 8036, Austria

Location

University Hospital Graz

Graz, 8036, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

University Hospital of Tübingen

Tübingen, 72076, Germany

Location

University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes MellitusObesityDiabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Andreas Fritsche, Prof. Dr.

    University Hospital of Tübingen

    PRINCIPAL INVESTIGATOR

  • Hermann Toplak, Prof. Dr.

    University Hospital Graz

    PRINCIPAL INVESTIGATOR

  • Peter Diem, Prof. Dr.

    Bern University Hospital

    STUDY CHAIR

  • Alexandra Kautzky-Willer, Prof. Dr.

    Medical University Vienna

    STUDY CHAIR

  • Thomas Pieber, Univ. Prof. Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 11, 2008

Study Start

November 1, 2007

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

AU(3)DE(1)CH(1)