Study to assess the efficacy and safety of a basal insulin (Glargine 300) on glycemic control type 2 diabetic patients during hospitalization and at discharge.

Phase 1

• Conditions: Type 2 Diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; MedDRA version: 18.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861

• Registration Number: EUCTR2015-004715-20-ES
• Lead Sponsor: SANOFI-AVENTIS, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

- Subjects >18 and <75 years old.
- Previous diagnosis of T2D.
- Admitted to medical wards with a planned duration of hospitalization of at least 7 days in a haemodynamically stable situation (maximum of 2 weeks).
- Treated with basal insulin and/or non-insulin treatments prior to admission.
- Poorly controlled on admission: HbA1c between 8% and 10%.
- Signed informed consent.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

- Type 1 Diabetes Mellitus.
- Admission to hospital for decompensation of diabetes.
- Any psychiatric or neurological disability preventing follow-up
- Critical illness.
- Previous treatment with premix or rapid acting insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week).
- Glomerular filtration rate (GFR) < 30 ml/min measured by MDRD-4 equation.
-Very high-risk patients who need mandatory insulin therapy at discharge (Treatment with corticoesteroids or pancreatic insufficiency (Pancreatitis / surgery).
-Participation in any other study.

Study & Design

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