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
  • Phase

    Phase 3
  • Study Type

  • Status

  • Study Participants

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 Started
Nov 30
Last Update
Nov 01

Drug insulin Levemir

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

Drug insulin Lantus

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

insulin Levemir Experimental

insulin Lantus Experimental


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
No Results Posted