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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Drug: insulin Levemir
* Drug: insulin Lantus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin Levemir<br> | Drug: insulin Levemir<br>* The participant will receive an insulin dose of insulin Levemir at dinner subcutaneously according to a dosing algorithm.<br>|
| Experimental: insulin Lantus<br> | Drug: insulin Lantus<br>* The participant will receive an insulin dose of the insulin Lantus at dinner subcutaneously according to a dosing algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin therapy, hepatic fat, type 2 diabetes, body composition, comparison of insulin detemir and insulin glargine, Changes in Hepatic Fat, Obesity