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 |
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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
Scientific
University Hospital Basel
Divison of Endocrinology, Diabetology & Clinical Nutrition
Basel
4031
Switzerland
Phone | +41 (0)61 265 5078 |
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puderj@uhbs.ch |
Study information
Study design | Randomized cross-over trial with 2 insulins (determir and glargine) and 2 dosages each |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
Division of Endocrinology, Diabetology and Clinical Nutrition
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
Phone | +41 (0)61 265 5078 |
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puderj@uhbs.ch | |
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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 16/08/2018 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added.