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Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Novo Nordisk A/S
Information provided by:
Munich Municipal Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : July 2004
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. postprandial blood glucose at the end of the study and its change from baseline. [ Time Frame: 24-48 months treatment period ]

Secondary Outcome Measures :
  1. diastolic myocardial function [ Time Frame: 24-48 months treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetes, insulin therapy

Exclusion Criteria:

  • type 1 diabetes, BMI >40, pregnancy,

Information from the National Library of Medicine

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 identifier (NCT number): NCT00747409

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Staedt. Klinikum Muenchen Bogenhausen
Munich, Bavaria, Germany, 81925
Sponsors and Collaborators
Munich Municipal Hospital
Novo Nordisk A/S
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Petra-Maria Schumm-Draeger, Munich Municipal Hospital Identifier: NCT00747409    
Other Study ID Numbers: AnaHum
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008
Keywords provided by Munich Municipal Hospital:
postprandial glucose, diastolic function, analogue insulins
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs