Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/04/2006
Date assigned
09/05/2006
Last edited
09/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jardena Puder

ORCID ID

Contact details

University Hospital Basel
Divison of Endocrinology
Diabetology & Clinical Nutrition
Basel
4031
Switzerland
+41 (0)61 265 5078
puderj@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Approved by the Local Ethics Committee of the University of Basel (EKBB) on 16/01/2003, reference number 295/05

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes, obesity

Intervention

Application of insulin determir (Levemir) versus insulin glargine (Lantus)

Intervention type

Drug

Phase

Not Specified

Drug names

Insulin detemir (Levemir) and insulin glargine (Lantus)

Primary outcome measures

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 trial start date

20/04/2006

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

8-12

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

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Division of Endocrinology
Diabetology and Clinical Nutrition
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
+41 (0)61 265 5078
puderj@uhbs.ch

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Novo Nordisk AG, Switzerland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundations

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes