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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR950 |
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Date of registration:
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27/03/2007 |
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Primary sponsor: |
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Public title:
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Differences in glucose production, lipolysis and proteolysis during different basal insulins, in patients with type 2 diabetes.
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Scientific title:
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Differences in glucose production, lipolysis and proteolysis during different basal insulins, in patients with type 2 diabetes.
- BASIN |
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Date of first enrolment:
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1/8/2007 |
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Target sample size:
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60 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=950 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.R.
Soeters |
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Address:
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Academic Medical Center (AMC)
Department of Endocrinology & Metabolism, F5-162
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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m.r.soeters@amc.uva.nl |
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Affiliation:
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Name:
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M.R.
Soeters |
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Address:
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Academic Medical Center (AMC)
Department of Endocrinology & Metabolism, F5-162
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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m.r.soeters@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Caucasian male patients with DM II;
2. Basal bolus insulin therapy with NPH, detemir or glargine for at least 1 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 40-65;
7. BMI 26-30 kg/m2
Exclusion criteria: 1. Major flaws in injection technique, as indicated by subcutaneous infiltration;
2. Creatinine > 100 µmol/L or diabetic nephropathy;
3. Abnormal liver enzymes (>2x upper limit of normal) and fasting triglycerides > 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 (>5/day);
9. Fever/infection;
10. Dietary fat content >75%
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus type 2 (DM type II)
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Intervention(s)
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The patients are admitted to the metabolic unit of the Academic Medical Center 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 HGP, lipolysis and proteolysis will start 1 h after the administration of the basal insulin at bedtime.
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Primary Outcome(s)
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1. Hepatic glucose production;
2. Lipolysis;
3. Proteolysis
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Secondary Outcome(s)
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1. Plasma Glucose;
2. Free fatty acids levels.
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Secondary ID(s)
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ISRCTN71468135
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Source(s) of Monetary Support
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Novo Nordisk Farma B.V.
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