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Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

NCT ID: NCT00747409

Last Updated: 2008-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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postprandial glucose, diastolic function, analogue insulins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Hum

use of human regular insulin and NPH insulin

Group Type ACTIVE_COMPARATOR

human regular insulin and NPH insulin (Actrapid, Protaphne)

Intervention Type DRUG

basal-bolus therapy with human regular and NPH insulin

Ana

use of insulin aspart and insulin detemir

Group Type ACTIVE_COMPARATOR

insulin aspart and detemir (NovoRapid, Levemir)

Intervention Type DRUG

use of basal-bolus therapy with insulin aspart and detemir

Interventions

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insulin aspart and detemir (NovoRapid, Levemir)

use of basal-bolus therapy with insulin aspart and detemir

Intervention Type DRUG

human regular insulin and NPH insulin (Actrapid, Protaphne)

basal-bolus therapy with human regular and NPH insulin

Intervention Type DRUG

Other Intervention Names

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Insulin NovoRapid, Insulin Levemir Insulin Actrapid, Insulin Protaphne

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes, insulin therapy

Exclusion Criteria

* type 1 diabetes, BMI \>40, pregnancy,
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Munich Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Munich Municipal Hospital

Principal Investigators

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Petra-Maria Schumm-Draeger, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Munich Academic Teaching Hospital Bogenhausen

Helene von Bibra, MD, PHD

Role: STUDY_CHAIR

Munich Academic Teaching Hospital Bogenhausen

Locations

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Staedt. Klinikum Muenchen Bogenhausen

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15111514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15547039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10447514 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26772807 (View on PubMed)

Other Identifiers

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AnaHum

Identifier Type: -

Identifier Source: org_study_id