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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

Primary Purpose

Diabetes, Obesity

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

insulin Levemir

insulin Lantus

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University Graz
University Hospital Graz
Medical University Vienna
University Hospital of Tübingen
University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

insulin Levemir

insulin Lantus

Arm Description

Outcomes

Primary Outcome Measures

To describe changes in hepatic fat content between groups.

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.

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

To describe changes in waist and hip circumferences between groups.

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

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

To evaluate the daily insulin dose between groups.

To describe the fasting blood glucose between groups.

To evaluate hypoglycaemia between groups.

To evaluate safety between groups.

Full Information

NCT ID

NCT00656422

First Posted

April 4, 2008

Last Updated

October 31, 2012

Sponsor

University Hospital Tuebingen

Collaborators

Medical University of Vienna, University of Bern, CenTrial GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00656422

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Tuebingen

Collaborators

Medical University of Vienna, University of Bern, CenTrial GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Obesity

Keywords

insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

insulin Levemir

Arm Type

Experimental

Arm Title

insulin Lantus

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin Levemir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

insulin Lantus

Intervention Description

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

Primary Outcome Measure Information:

Title

To describe changes in hepatic fat content between groups.

Time Frame

week 26, week 52

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

week 26, week 52

Title

To describe changes in waist and hip circumferences between groups.

Time Frame

weel 26, week 52

Title

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

Time Frame

week 26, week 52

Title

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

Time Frame

week 26, week 52

Title

To evaluate the daily insulin dose between groups.

Time Frame

1 year

Title

To describe the fasting blood glucose between groups.

Time Frame

1 year

Title

To evaluate hypoglycaemia between groups.

Time Frame

1 year

Title

To evaluate safety between groups.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: