|- candidate number||2533|
|- NTR Number||NTR950|
|- Date ISRCTN created||30-mei-2007|
|- date ISRCTN requested||22-mei-2007|
|- Date Registered NTR||27-mrt-2007|
|- Secondary IDs||1 |
|- Public Title||Differences in glucose production, lipolysis and proteolysis during different basal insulins, in patients with type 2 diabetes.
|- Scientific Title||Differences in glucose production, lipolysis and proteolysis during different basal insulins, in patients with type 2 diabetes.
|- hypothesis||Differences exist in duration of effect of insulin detemir, insulin glargine or NPH insulin on glucose production, lipolysis and proteolysis in patients with type 2 diabetes mellitus.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- 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 Ámol/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;
7. Drugs interfering with insulin sensitivity and lipolysis, other than metformin;
8. Alcohol abuse (>5/day);
10. Dietary fat content >75%
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-aug-2007|
|- planned closingdate||1-aug-2008|
|- Target number of participants||60|
|- Interventions||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. |
|- Primary outcome||1. Hepatic glucose production;
|- Secondary outcome||1. Plasma Glucose;
2. Free fatty acids levels.|
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||MD. M.R. Soeters|
|- CONTACT for SCIENTIFIC QUERIES||MD. M.R. Soeters|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Endocrinology and Metabolism|
(Source(s) of Monetary or Material Support)
|Novo Nordisk Farma B.V. |
|- Brief summary||Background:
Insulin does not only regulate glucose homeostasis but also suppresses lipolysis and proteolysis. Inhibiting lipolysis and proteolysis during the night ( as it is physiological in non obese healthy subjects) seems to have a beneficial effect on insulin sensitivity in type 2 diabetics. This may be caused by the decreased insulin resistant effect of free fatty acids. It is unknown how the long acting insulins (NPH insulin, insulin levemir en insulin glargine) behave in this respect. The insulins are currently registered and used in the treatment of diabetes mellitus.
To investigate the effects of NPH insulin, insulin levemir and insulin glargine on post-absorptive glucose production, lipolysis and proteolysis in subjects with type 2 diabetes mellitus patients. Besides this, the inter-individual variability of the concerned insulines will be investigated.
DM II patients will be included and all will undergo one study day with one of the concerned insulins. Patients will be admitted to the hospital and will receive the concerned insulin dose at bedtime. Effects will be monitored during 24 hours after insulin administration. The insulin dose will be titrated during the 2 weeks preceding the study day. Patients will consume a diet balanced in carbohydrate, fat and protein.
60 male type 2 diabetes patients (three groups of 20 persons) who have been using a long acting insulin for at least one year ( dosage: 20- 40U, fasting glucose level 7,5-8,5 mmol/L, HbA1C 8-9%, age 40-60 years and BMI 27-30 kg/M2.
On study days glucose production, lipolysis and proteolysis will be measured with the stable isotope technique.
Differences in suppression of endogenous glucose production, lipolysis and proteolysis of the concerned insulins.
The burden of this study is negligible (attendance on the study day). There are no risks.
|- Main changes (audit trail)|
|- RECORD||27-mrt-2007 - 11-jun-2007|