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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Drug: insulin Levemir; Drug: insulin Lantus

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Graz
  • Graz, Austria, 8036
    • University Hospital Graz
  • Vienna, Austria, 1090
    • Medical University Vienna
• Germany
  • Tübingen, Germany, 72076
    • University Hospital of Tübingen
• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To describe changes in hepatic fat content between groups.	week 26, week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
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
To evaluate the daily insulin dose between groups.	1 year
To describe the fasting blood glucose between groups.	1 year
To evaluate hypoglycaemia between groups.	1 year
To evaluate safety between groups.	1 year

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2007

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 7, 2008
• First Posted (ESTIMATE): April 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Obesity; type 2 diabetes; body composition; insulin therapy; hepatic fat; comparison of insulin detemir and insulin glargine; Changes in Hepatic Fat
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Body Weight Changes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Gain; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Detemir
• Other Study ID Numbers: N-ISP-1; LEV-002