NCT00747409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

Enrollment Period

4.7 years

First QC Date

September 4, 2008

Last Update Submit

September 4, 2008

Conditions

Type 2 Diabetes Mellitus

Keywords

postprandial glucose, diastolic function, analogue insulins

Outcome Measures

Primary Outcomes (1)

  • postprandial blood glucose at the end of the study and its change from baseline.

    24-48 months treatment period

Secondary Outcomes (1)

  • diastolic myocardial function

    24-48 months treatment

Study Arms (2)

Hum

ACTIVE COMPARATOR

use of human regular insulin and NPH insulin

Drug: human regular insulin and NPH insulin (Actrapid, Protaphne)

Ana

ACTIVE COMPARATOR

use of insulin aspart and insulin detemir

Drug: insulin aspart and detemir (NovoRapid, Levemir)

Interventions

insulin aspart and detemir (NovoRapid, Levemir)DRUG

use of basal-bolus therapy with insulin aspart and detemir

Also known as: Insulin NovoRapid, Insulin Levemir
Ana
human regular insulin and NPH insulin (Actrapid, Protaphne)DRUG

basal-bolus therapy with human regular and NPH insulin

Also known as: Insulin Actrapid, Insulin Protaphne
Hum

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes, insulin therapy

You may not qualify if:

  • type 1 diabetes, BMI \>40, pregnancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staedt. Klinikum Muenchen Bogenhausen

Munich, Bavaria, 81925, Germany

Location

Related Publications (4)

  • 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.

    PMID: 15111514BACKGROUND

  • 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.

    PMID: 15547039BACKGROUND

  • 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.

    PMID: 10447514BACKGROUND

  • 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.

    PMID: 26772807DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin AspartInsulin DetemirInsulinInsulin, Isophaneinsulin, neutral

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-ActingProinsulin

Study Officials

  • Petra-Maria Schumm-Draeger, MD, PHD

    Munich Academic Teaching Hospital Bogenhausen

    PRINCIPAL INVESTIGATOR

  • Helene von Bibra, MD, PHD

    Munich Academic Teaching Hospital Bogenhausen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

July 1, 2004

Primary Completion

March 1, 2009

Study Completion

June 1, 2009

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

DE(1)