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Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Munich Municipal Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novo Nordisk
Information provided by:
Munich Municipal Hospital
ClinicalTrials.gov Identifier:
NCT00747409
First received: September 4, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: insulin aspart and detemir (NovoRapid, Levemir)
Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Munich Municipal Hospital:

Primary Outcome Measures:
  • postprandial blood glucose at the end of the study and its change from baseline. [ Time Frame: 24-48 months treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diastolic myocardial function [ Time Frame: 24-48 months treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes, insulin therapy

Exclusion Criteria:

  • type 1 diabetes, BMI >40, pregnancy,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747409

Locations
Germany
Staedt. Klinikum Muenchen Bogenhausen
Munich, Bavaria, Germany, 81925
Sponsors and Collaborators
Munich Municipal Hospital
Novo Nordisk
Investigators
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
  More Information

Publications:

Responsible Party: Prof. Dr. Petra-Maria Schumm-Draeger, Munich Municipal Hospital
ClinicalTrials.gov Identifier: NCT00747409     History of Changes
Other Study ID Numbers: AnaHum
Study First Received: September 4, 2008
Last Updated: September 4, 2008
Health Authority: Germany: Competence-Center-Quality-Management of the Staedt. Klinikum Muenchen GmbH

Keywords provided by Munich Municipal Hospital:
postprandial glucose, diastolic function, analogue insulins

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013