Optimization of glycaemic control using a tablet-based insulin titrationalgorithm in hospitalized patients with type 2 diabetes

• Conditions: Diabetes mellitus type 2; MedDRA version: 16.0Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 16.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-001295-38-AT
• Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin. Abt. für Endokrinologie und Stoffwechsel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-28
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Informed consent obtained after being advised of the nature of the study
- Male or female aged =18 years
- Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Type 1 diabetes, gestational diabetes
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
- Pregnancy
- Any mental condition rendering the patient incapable of giving his consent
- Known or suspected allergy to insulin glargine or insulin aspart
- Continuous parenteral nutrition
- Participation in another trial which can influence the software algorithm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified