Contact information
Type
Scientific
Primary contact
Dr M.R. Soeters
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Endocrinology & Metabolism
F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667672 / 5669111
M.R.Soeters@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
BASIN
Study hypothesis
Differences exist in duration of effect of insulin detemir, insulin glargine or Neutral Protamine Hagedorn (NPH) insulin on glucose production, lipolysis and proteolysis in patients with type two diabetes mellitus.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diabetes Mellitus type 2 (DM type II)
Intervention
The patients are admitted to the metabolic unit of the Academic Medical Centre at 4.30 pm, with the last meal and usual insulin dosage of short-acting insulin taken at 12.00 am. The long-acting insulin is injected in the subcutis of the thigh at bedtime. Measurements of Hepatic Glucose Production (HGP), lipolysis and proteolysis will start one hour after the administration of the basal insulin at bedtime.
Intervention type
Drug
Phase
Not Specified
Drug names
Insulin
Primary outcome measures
1. Hepatic Glucose Production (HGP)
2. Lipolysis
3. Proteolysis
Secondary outcome measures
1. Plasma Glucose
2. Free fatty acids levels
Overall trial start date
01/08/2007
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Caucasian male patients with Diabetes Mellitus Type Two (DM II)
2. Basal bolus insulin therapy with NPH, detemir or glargine for at least one year
3. Basal insulin dosage: 30 ± 10 U
4. Fasting plasma glucose: 7.5 - 10.0 mmol/l
5. HbA1c 7.5 - 9%
6. Age 40 to 65 years
7. Body Mass Index (BMI) 26 - 30 kg/m^2
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
60
Participant exclusion criteria
1. Major flaws in injection technique, as indicated by subcutaneous infiltration
2. Creatinine greater than 100 µmol/L or diabetic nephropathy
3. Abnormal liver enzymes (greater than 2 x upper limit of normal) and fasting triglycerides greater than 3 mmol/L
4. Clinically manifest autonomic neuropathy
5. Macrovascular complications of DM II, except for peripheral arterial disease
6. Epilepsy
7. Drugs interfering with insulin sensitivity and lipolysis, other than metformin
8. Alcohol abuse (greater than 5/day)
9. Fever/infection
10. Dietary fat content greater than 75%
Recruitment start date
01/08/2007
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Novo Nordisk (Denmark)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Denmark
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