Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
insulin aspart and detemir (NovoRapid, Levemir)
human regular insulin and NPH insulin (Actrapid, Protaphne)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring postprandial glucose, diastolic function, analogue insulins
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes, insulin therapy
Exclusion Criteria:
- type 1 diabetes, BMI >40, pregnancy,
Sites / Locations
- Staedt. Klinikum Muenchen Bogenhausen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hum
Ana
Arm Description
use of human regular insulin and NPH insulin
use of insulin aspart and insulin detemir
Outcomes
Primary Outcome Measures
postprandial blood glucose at the end of the study and its change from baseline.
Secondary Outcome Measures
diastolic myocardial function
Full Information
NCT ID
NCT00747409
First Posted
September 4, 2008
Last Updated
September 4, 2008
Sponsor
Munich Municipal Hospital
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT00747409
Brief Title
Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Munich Municipal Hospital
Collaborators
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes. Especially, fast acting insulin analogues lower postprandial glucose levels more effectively than human regular insulin. However, it is not known whether therapy with analogue insulins can also improve the subclinically impaired myocardial function in type 2 diabetes. This prospective, randomized, open long term study compared the effects of a basal-bolus insulin therapy with analogue insulins versus human insulins on metabolic control and systolic and diastolic myocardial function, testing the hypothesis that optimized postprandial glucose control improves cardiac function and cardiovascular risk.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
postprandial glucose, diastolic function, analogue insulins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hum
Arm Type
Active Comparator
Arm Description
use of human regular insulin and NPH insulin
Arm Title
Ana
Arm Type
Active Comparator
Arm Description
use of insulin aspart and insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin aspart and detemir (NovoRapid, Levemir)
Other Intervention Name(s)
Insulin NovoRapid, Insulin Levemir
Intervention Description
use of basal-bolus therapy with insulin aspart and detemir
Intervention Type
Drug
Intervention Name(s)
human regular insulin and NPH insulin (Actrapid, Protaphne)
Other Intervention Name(s)
Insulin Actrapid, Insulin Protaphne
Intervention Description
basal-bolus therapy with human regular and NPH insulin
Primary Outcome Measure Information:
Title
postprandial blood glucose at the end of the study and its change from baseline.
Time Frame
24-48 months treatment period
Secondary Outcome Measure Information:
Title
diastolic myocardial function
Time Frame
24-48 months treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes, insulin therapy
Exclusion Criteria:
type 1 diabetes, BMI >40, pregnancy,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra-Maria Schumm-Draeger, MD, PHD
Organizational Affiliation
Munich Academic Teaching Hospital Bogenhausen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helene von Bibra, MD, PHD
Organizational Affiliation
Munich Academic Teaching Hospital Bogenhausen
Official's Role
Study Chair
Facility Information:
Facility Name
Staedt. Klinikum Muenchen Bogenhausen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81925
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15111514
Citation
Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care. 2004 May;27(5):1023-7. doi: 10.2337/diacare.27.5.1023.
Results Reference
background
PubMed Identifier
15547039
Citation
von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Ryden L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. doi: 10.1136/hrt.2003.020842. No abstract available.
Results Reference
background
PubMed Identifier
10447514
Citation
Shaw JE, Hodge AM, de Courten M, Chitson P, Zimmet PZ. Isolated post-challenge hyperglycaemia confirmed as a risk factor for mortality. Diabetologia. 1999 Sep;42(9):1050-4. doi: 10.1007/s001250051269. Erratum In: Diabetologia 1999 Dec;42(12):1444.
Results Reference
background
PubMed Identifier
26772807
Citation
von Bibra H, Siegmund T, Kingreen I, Riemer M, Schuster T, Schumm-Draeger PM. Effects of analogue insulin in multiple daily injection therapy of type 2 diabetes on postprandial glucose control and cardiac function compared to human insulin: a randomized controlled long-term study. Cardiovasc Diabetol. 2016 Jan 16;15:7. doi: 10.1186/s12933-015-0320-2.
Results Reference
derived
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Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes
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