MedDataX Logo

Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.

NCT ID: NCT00254085

Last Updated: 2005-11-15

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with Type 2 diabtes has a defect in the insulinsecretion combined with an increased insulin resistance. At an intravenously glucosestimulation, patients with Type 2 diabtes has a decresed first phase insulin response compared to healty peoples. Because the hyperglycemia after meal, observed i Type 2 diabetics patients, is related to the defect in the first phase insulin response it is our hypothesis that substitution of the first phase insulin response with a little dose of insulin could normalise the blood glucose after the meal.

20 patients with Type 2 diabetes will in a randomised, placebocontrolled, dobble-dummy study be included for three days treatment with Insulin aspart vs placebo. Primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 diabtes Postprandial hyperglycemia Insulin treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Insulin Aspart

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

\-

Exclusion Criteria

Ongoing treatment with antidiabetic medicine Pregnancy and lactation -
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charlotte Gredal, MD

Role: PRINCIPAL_INVESTIGATOR

Gentofte University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gentofte University Hospital

Hellerup, Hellerup, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Charlotte Gredal, MD

Role: CONTACT

Phone: +45 39 77 79 76

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Charlotte Gredal, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19016075 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KA 03092s

Identifier Type: -

Identifier Source: secondary_id

2612-2368

Identifier Type: -

Identifier Source: org_study_id