Pharmacokinetics and pharmacodynamics of insulin detemir (Levemir®) and insulin glargine (Lantus®) after subcutaneous injection of increasing doses into morbidly obese type 2 diabetic subjects

ISRCTN ISRCTN57547229
DOI https://doi.org/10.1186/ISRCTN57547229
Secondary identifying numbers N/A
Submission date
07/04/2006
Registration date
09/05/2006
Last edited
01/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Jardena Puder
Scientific

University Hospital Basel
Divison of Endocrinology, Diabetology & Clinical Nutrition
Basel
4031
Switzerland

Phone +41 (0)61 265 5078
Email puderj@uhbs.ch

Study information

Study designRandomized cross-over trial with 2 insulins (determir and glargine) and 2 dosages each
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titlePharmacokinetics and pharmacodynamics of insulin detemir (Levemir®) and insulin glargine (Lantus®) after subcutaneous injection of increasing doses into morbidly obese type 2 diabetic subjects
Study acronymINSULIN-KINETICS
Study hypothesisThe primary aim of this study is to compare the dose-response relationship of moderate and of high doses of insulin detemir and of insulin glargine in severely obese type 2 diabetic subjects.
Ethics approval(s)Approved by the Local Ethics Committee of the University of Basel (EKBB) on 16/01/2003, reference number 295/05
ConditionDiabetes, obesity
InterventionApplication of insulin determir (Levemir) versus insulin glargine (Lantus)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Insulin detemir (Levemir) and insulin glargine (Lantus)
Primary outcome measurePharmacodynamics of the two insulins (detemir and glargine)
Secondary outcome measures1. Pharmacokinetics of the two insulins (detemir and glargine)
2. Correlation pharmacodynamics and (central) obesity
Overall study start date20/04/2006
Overall study end date30/04/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants8-12
Participant inclusion criteria1. History of type 2 diabetes mellitus
2. Age 18-65 years
3. Body mass index >35 kg/m^2
4. HbA1c <10%
Participant exclusion criteria1. Any severely active hepatic, cardiovascular, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease
2. Pregnant or breast feeding women
3. Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or an intrauterine device (IUD)
4. Subjects refusing or unable to give written informed consent
Recruitment start date20/04/2006
Recruitment end date30/04/2007

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

University Hospital Basel (Switzerland)
University/education

Division of Endocrinology, Diabetology and Clinical Nutrition
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Phone +41 (0)61 265 5078
Email puderj@uhbs.ch
ROR logo "ROR" https://ror.org/04k51q396

Funders

Funder type

Industry

Novo Nordisk AG, Switzerland

No information available

Foundations

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/08/2018 01/02/2019 Yes No

Editorial Notes

01/02/2019: Publication reference added.