Efficacy and mechanisms of a short course of intensified insulin treatment on remission or responsiveness to oral therapy in type 2 diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001509-28-IT

Enrollment

Registered

2011-12-22

Start date

2012-03-01

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

Newly-diagnosed type 2 diabetes patients. MedDRA version: 14.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: HUMALOG*BASAL 10PEN 3ML 100U/M Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN LISPRO CAS Number: 133107-64-9 Concentration unit: U/ml unit(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study will include patients of either sex reporting to the diabetes clinic with new-onset signs and symptoms, a fasting plasma glucose =7 mmol/l or a 2-hour plasma glucose =11.1 mmol/l on a standard OGTT or a HbA1c in the range 6.5-9.5%. Age range will be 18-70 years, body mass index 18-45 kg.m-2. Are the trial subjects under 18? no Number of subjects for this age range: 0 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 15

Exclusion criteria

Exclusion criteria: Exclusion criteria will be recent (<6 months) acute coronary syndrome, stroke or major surgery; childbearing potential not using contraceptives or pregnancy; major cardiac, hepatic, psychiatric or endocrine disorder; estimated glomerular filtration rate <50 ml.min-1, subjects not capable of giving informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure changes in ß-cell glucose sensitivity between baseline (at diagnosis) and at time of rescue therapy or study end.;Secondary Objective: To measure changes in glycaemic control and insulin sensitivity between baseline (at diagnosis) and time of rescue therapy or study end; to estimate rates and time-course of diabetes remission and resolution.;Primary end point(s): ß-cell glucose sensitivity measured by OGTT;Timepoint(s) of evaluation of this end point: At baseline, end of six wees of stabilisied insulin treatment and then at 2, 6 and 12 months.	—

Measure

Time frame

Main Objective: To measure changes in ß-cell glucose sensitivity between baseline (at diagnosis) and at time of rescue therapy or study end.;Secondary Objective: To measure changes in glycaemic control and insulin sensitivity between baseline (at diagnosis) and time of rescue therapy or study end; to estimate rates and time-course of diabetes remission and resolution.;Primary end point(s): ß-cell glucose sensitivity measured by OGTT;Timepoint(s) of evaluation of this end point: At baseline, end of six wees of stabilisied insulin treatment and then at 2, 6 and 12 months.

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in glycaemic control and insulin sensitivity measured by OGTT and OGIS;Timepoint(s) of evaluation of this end point: At baseline, end of six wees of stabilisied insulin treatment and then at 2, 6 and 12 months.	—

Countries

Italy

Contacts

Public ContactU.O. DI MEDICINA GENERALE 3

AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

ferranni@ifc.cnr.it050-553272

Outcome results

None listed

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