Investigation of efficacy, safety and usability of the GlucoTab system with an integrated long-acting insulin scheme for type 2 diabetes in the geriatric care setting

Phase 1

• Conditions: Diabetes mellitus type 2; MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-000955-25-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Male or female aged = 65 years
Planned minimum stay of 1 week
Insulin planned as inpatient and/or discharge therapy
Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Instable corticosteroid therapy (>5 mg per day)
Known or suspected allergy to insulin glargine/ glulisine
Parenteral nutrition

Study & Design

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