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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

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 design	Randomized cross-over trial with 2 insulins (determir and glargine) and 2 dosages each
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Pharmacokinetics and pharmacodynamics of insulin detemir (Levemir®) and insulin glargine (Lantus®) after subcutaneous injection of increasing doses into morbidly obese type 2 diabetic subjects
Study acronym	INSULIN-KINETICS
Study hypothesis	The 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
Condition	Diabetes, obesity
Intervention	Application of insulin determir (Levemir) versus insulin glargine (Lantus)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Insulin detemir (Levemir) and insulin glargine (Lantus)
Primary outcome measure	Pharmacodynamics of the two insulins (detemir and glargine)
Secondary outcome measures	1. Pharmacokinetics of the two insulins (detemir and glargine) 2. Correlation pharmacodynamics and (central) obesity
Overall study start date	20/04/2006
Overall study end date	30/04/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	8-12
Participant inclusion criteria	1. History of type 2 diabetes mellitus 2. Age 18-65 years 3. Body mass index >35 kg/m^2 4. HbA1c <10%
Participant exclusion criteria	1. 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 date	20/04/2006
Recruitment end date	30/04/2007

University Hospital Basel

Basel
4031
Switzerland

University Hospital Basel (Switzerland)
University/education

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

Industry

Novo Nordisk AG, Switzerland

No information available

Foundations

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

01/02/2019: Publication reference added.