Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00747409
• Other study ID #: AnaHum
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 4, 2008
• Last updated: September 4, 2008
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: September 2008
• Source: Munich Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Competence-Center-Quality-Management of the Staedt. Klinikum Muenchen GmbH
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes, insulin therapy

Exclusion Criteria:

• type 1 diabetes, BMI >40, pregnancy,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• insulin aspart and detemir (NovoRapid, Levemir)
use of basal-bolus therapy with insulin aspart and detemir
• human regular insulin and NPH insulin (Actrapid, Protaphne)
basal-bolus therapy with human regular and NPH insulin

Locations

Country	Name	City	State
Germany	Staedt. Klinikum Muenchen Bogenhausen	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Munich Municipal Hospital	Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. Erratum in: Diabetologia 1999 Dec;42(12):1444. — View Citation

von Bibra H, Hansen A, Dounis V, Bystedt T, Malmberg K, Rydén L. Augmented metabolic control improves myocardial diastolic function and perfusion in patients with non-insulin dependent diabetes. Heart. 2004 Dec;90(12):1483-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial blood glucose at the end of the study and its change from baseline.		24-48 months treatment period	No
Secondary	diastolic myocardial function		24-48 months treatment	No