Effect of glicemia normalization in fasting conditions by insulinic intensive treatment on frequency of restenosis after periferic angioplastic in patients affected by diabetes mellitus type II. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000686-30-IT

Enrollment

Registered

2008-02-20

Start date

2008-02-26

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus type II MedDRA version: 9.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus

Interventions

Trade Name: LANTUS Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin glargine Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100- T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patients of both sex aged between 30 and 75 years old;-female in climateric state;-patients able to give their consent; patients affected by diabetes mellitus type IIFPG >7.0 mmol/l or PPG  11.1 mmol/l or prevous diabetes diagnosis etc. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -diabetes mellitus type I; -positivity forAb antiGAD dosed by RIA method; -rejection of sc teraphy; -acute limb ischemia; -Buerger illness; etc.

Design outcomes

Primary

Measure	Time frame
Main Objective: to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in: -angiographic stenosis reduction after periferc angioplastic -increase of % of clinical success to FU etc -;Secondary Objective: to verify if fasting normoglicemia obtained by intensive insulinic treatment is able to reduce or to avoid planned or not palnned amputations;Primary end point(s): to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in: -angiographic stenosis reduction after periferc angioplastic -increase of % of clinical success to FU etc -	—

Measure

Time frame

Main Objective: to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in: -angiographic stenosis reduction after periferc angioplastic -increase of % of clinical success to FU etc -;Secondary Objective: to verify if fasting normoglicemia obtained by intensive insulinic treatment is able to reduce or to avoid planned or not palnned amputations;Primary end point(s): to estabilish the role of the fasting mormoglicemia obtained by intensive insulinic treatment for 6 months in: -angiographic stenosis reduction after periferc angioplastic -increase of % of clinical success to FU etc -

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026