Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00747409|
Recruitment Status : Unknown
Verified September 2008 by Munich Municipal Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 5, 2008
Last Update Posted : September 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: insulin aspart and detemir (NovoRapid, Levemir) Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)||Phase 4|
This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy. After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.
In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart). Both treatment arms will be titrated to identical glycemic goals (fasting blood glucose <110 mg/dL and post prandial blood glucose <150 mg/dL).
All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit. Furthermore, they are encouraged to keep records of any episode of hypoglycemia throughout the study. Outpatient visits for metabolic control are every 3 months and ultrasound and blood tests every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized, Long-Term Study About the Effects of Analogue Versus Human Insulin Based Regimens (Insulin Detemir and Aspart Versus NPH- and Regular Human Insulin) on Metabolic Control and Myocardial Function in People With Type 2 Diabetes.|
|Study Start Date :||July 2004|
|Estimated Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||June 2009|
Active Comparator: Hum
use of human regular insulin and NPH insulin
Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)
basal-bolus therapy with human regular and NPH insulin
Other Name: Insulin Actrapid, Insulin Protaphne
Active Comparator: Ana
use of insulin aspart and insulin detemir
Drug: insulin aspart and detemir (NovoRapid, Levemir)
use of basal-bolus therapy with insulin aspart and detemir
Other Name: Insulin NovoRapid, Insulin Levemir
- postprandial blood glucose at the end of the study and its change from baseline. [ Time Frame: 24-48 months treatment period ]
- diastolic myocardial function [ Time Frame: 24-48 months treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747409
|Staedt. Klinikum Muenchen Bogenhausen|
|Munich, Bavaria, Germany, 81925|
|Principal Investigator:||Petra-Maria Schumm-Draeger, MD, PHD||Munich Academic Teaching Hospital Bogenhausen|
|Study Chair:||Helene von Bibra, MD, PHD||Munich Academic Teaching Hospital Bogenhausen|