??CRETIN HORMONES AND THE ROLE OF METFORMIN IN THE TREATMENT OF TYPE 1 DIABETES MELLITUS

GUT-DERIVED INCRETIN HORMONES IN THE PATHOPHYSIOLOGY OF TYPE 1 DIABETES MELLITUS; EFFECT OF METFORMIN TREATMENT (THE INCREDIBLE-ME TRIAL) - INCREDIBLE ME

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003022-89-GR

Enrollment

Registered

2019-10-02

Start date

2019-10-18

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

GUT-DERIVED INCRETIN HORMONES IN THE PATHOPHYSIOLOGY OF TYPE 1 DIABETES MELLITUS

Interventions

Trade Name: Glucostop Product Name: Metformin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years • T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year from diagnosis) • Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII) 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 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

Exclusion criteria: • Acute or within the last 3 months cardiovascular disease • NYHA stage 3 or 4 heart failure • Uncontrolled angina • Liver failure [AST>135 IU/L or ALT>129IU/L (3 x the upper normal limit)] • Kidney failure or GFR 2-drinks per day or other substance abuse.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of metformin on fasting and postprandial GLP-1 and GIP secretion in adults with T1DM.;Secondary Objective: 1. To determine the effect of metformin on glycemic variability in adults with T1DM. 2. To determine the effect of metformin on plasma amino acids and metabolites profile in adults with T1DM. 3. To determine the effect of metformin on inflammation in adults with T1DM. 4. To evaluate the effect of metformin on the microbiome in adults with T1DM. ;Primary end point(s): The primary endpoint will be glucagon like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) secretion following a mixed meal.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: To determine the effect of metformin on fasting and postprandial GLP-1 and GIP secretion in adults with T1DM.;Secondary Objective: 1. To determine the effect of metformin on glycemic variability in adults with T1DM. 2. To determine the effect of metformin on plasma amino acids and metabolites profile in adults with T1DM. 3. To determine the effect of metformin on inflammation in adults with T1DM. 4. To evaluate the effect of metformin on the microbiome in adults with T1DM. ;Primary end point(s): The primary endpoint will be glucagon like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) secretion following a mixed meal.;Timepoint(s) of evaluation of this end point: 36 months

—

Secondary

Measure	Time frame
Secondary end point(s): • Change in glycemic variability • Change in plasma amino acids and metabolites profiling • Change in plasma markers of inflammation and adhesion molecules • Change in genes expression related to inflammation and endothelial function • Change in the intestinal microbiome ;Timepoint(s) of evaluation of this end point: 36 months	—

Countries

Greece

Contacts

Public ContactSECRETARY OF THE BOARD

HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

insepsis@otenet.gr00302107480662

Outcome results

None listed

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