Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Prospectively 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 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

http://www.amc.uva.nl/index.cfm?sid=818

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

Publication citations

Additional files

Editorial Notes