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 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Basel (Switzerland) |
| Funders | Novo Nordisk AG, Switzerland, Foundations |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Jardena Puder
Scientific
Scientific
University Hospital Basel
Divison of Endocrinology, Diabetology & Clinical Nutrition
Basel
4031
Switzerland
| Phone | +41 (0)61 265 5078 |
|---|---|
| puderj@uhbs.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized cross-over trial with 2 insulins (determir and glargine) and 2 dosages each |
| Secondary study design | Randomised controlled trial |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | Diabetes, obesity |
| Intervention | Application of insulin determir (Levemir) versus insulin glargine (Lantus) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin detemir (Levemir) and insulin glargine (Lantus) |
| Primary outcome measure(s) |
Pharmacodynamics of the two insulins (detemir and glargine) |
| Key secondary outcome measure(s) |
1. Pharmacokinetics of the two insulins (detemir and glargine) |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 12 |
| Key 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% |
| Key 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 |
| Date of first enrolment | 20/04/2006 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
