EUCTR2015-004715-20-ES
Active, not recruiting
Phase 1
Phase IV study to evaluate the safety and efficacy of the treatment of hyperglycemia with Gla-300 in basal-bolus regimen in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments and therapy intensification at discharge with basal insulin . - COBALTA
SANOFI-AVENTIS, S.A.0 sites106 target enrollmentJanuary 13, 2016
ConditionsType 2 DiabetesMedDRA version: 18.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsToujeo
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- SANOFI-AVENTIS, S.A.
- Enrollment
- 106
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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