Differences in glucose production, lipolysis and proteolysis during different BASal INsulins, in patients with type two diabetes
| ISRCTN | ISRCTN71468135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71468135 |
| Secondary identifying numbers | NL926 (NTR950) |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.R. Soeters
Scientific
Scientific
Academic Medical Centre (AMC)
Department of Endocrinology & Metabolism, F5-162
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667672 / 5669111 |
|---|---|
| M.R.Soeters@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Differences in glucose production, lipolysis and proteolysis during different BASal INsulins, in patients with type two diabetes |
| Study acronym | BASIN |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | 1. Hepatic Glucose Production (HGP) 2. Lipolysis 3. Proteolysis |
| Secondary outcome measures | 1. Plasma Glucose 2. Free fatty acids levels |
| Overall study start date | 01/08/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 60 |
| Key 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 |
| Key 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% |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/index.cfm?sid=818 |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Novo Nordisk (Denmark)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Novo Nordisk Global
- Location
- Denmark
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Editorial Notes
19/10/2021: Proactive update review. No publications found. Search options exhausted.
