|
Main
|
|
Note: This record shows only 22 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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00859079 |
|
Date of registration:
|
07/03/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
|
|
Scientific title:
|
Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients |
|
Date of first enrolment:
|
June 2006 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00859079 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Austria
| | | | | | | |
|
Contacts
|
|
Name:
|
Thomas C Wascher, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
Exclusion Criteria:
- Patients with heart failure > NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine > 3 mg/dl)
- Acute infection
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus Type 2
|
|
Hyperglycemia
|
|
Intervention(s)
|
|
Drug: Human regular insulin intravenously
|
|
Drug: GLP-1
|
|
Primary Outcome(s)
|
|
time to reach a plasma glucose below 115 mg/dl
[Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min]
|
|
Secondary Outcome(s)
|
|
plasma glucose after 2 and 4 hours as well as maximum glycemia
[Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min]
|
|
number of hypoglycaemic episodes
[Time Frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min]
|
|
Secondary ID(s)
|
|
TCW-GLP1-1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|