NCT00254085

Brief Summary

The purpose of the project is to shown whether a little dose of a short acting insulin analogue given 3 time daily before the meals compared with placebo could normalise the increase in blood glucose after teh meals in diet treated Type 2 diabetic patients.

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
20

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_4 type-2-diabetes

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

March 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 15, 2005

Status Verified

September 1, 2005

First QC Date

November 14, 2005

Last Update Submit

November 14, 2005

Conditions

Type 2 Diabetes

Keywords

Type 2 diabtesPostprandial hyperglycemiaInsulin treatment

Outcome Measures

Primary Outcomes (1)

  • Blood glucose fluctuations

Secondary Outcomes (1)

  • number of hypoglycemia

Interventions

Insulin AspartDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabtes according to the WHO criteria Fasting blood glucose \>7 HbA1c between 6-9 Normal liver function Normal renal function

You may not qualify if:

  • Ongoing treatment with antidiabetic medicine Pregnancy and lactation -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte University Hospital

Hellerup, Hellerup, 2900, Denmark

RECRUITING

Related Publications (1)

  • Gredal C, Rosenfalck AM, Dejgaard A, Hilsted J. Targeting postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes with a fixed, weight-based dose of insulin Aspart. Scand J Clin Lab Invest. 2008;68(8):739-44. doi: 10.1080/00365510802207982.

    PMID: 19016075DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Interventions

Insulin Aspart

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 Proteins

Study Officials

  • Charlotte Gredal, MD

    Gentofte University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Gredal, MD

CONTACT

+45 39 77 79 76chgr@gentoftehosp.kbhamt.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

November 15, 2005

Record last verified: 2005-09

Locations

DK(1)