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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00656422
• Other study ID #: N-ISP-1
• Secondary ID: LEV-002
• Status: Terminated
• Phase: Phase 3
• First received: April 4, 2008
• Last updated: October 31, 2012
• Start date: November 2007

Study information

• Verified date: October 2012
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyAustria: EthikkommissionSwitzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus, Type 2
• Obesity
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	University Hospital Graz	Graz
Austria	Medical University Vienna	Vienna
Germany	University Hospital of Tübingen	Tübingen
Switzerland	University Hospital	Bern

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Tuebingen	CenTrial GmbH, Medical University of Vienna, University of Bern

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe changes in hepatic fat content between groups.		week 26, week 52	No
Secondary	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	Yes
Secondary	To evaluate changes in body fat and visceral adipose tissue between groups.		week 26, week 52	No
Secondary	To describe changes in waist and hip circumferences between groups.		weel 26, week 52	No
Secondary	To describe changes in eating behavior and food selection between groups.		week 26, week 52	No
Secondary	To describe changes in well being and disease perception between groups.		week 26, week 52	No
Secondary	To evaluate the daily insulin dose between groups.		1 year	No
Secondary	To describe the fasting blood glucose between groups.		1 year	No
Secondary	To evaluate hypoglycaemia between groups.		1 year	Yes
Secondary	To evaluate safety between groups.		1 year	Yes