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

University Hospital Tuebingen

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Obesity

Treatments: Drug: insulin Levemir; Drug: insulin Lantus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00656422

LEV-002

N-ISP-1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

insulin Levemir

Experimental group

Treatment:

Drug: insulin Levemir

insulin Lantus

Experimental group

Treatment:

Drug: insulin Lantus