NCT04177303

Brief Summary

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

October 30, 2019

Last Update Submit

February 17, 2020

Conditions

Type 1 Diabetes Mellitus

Keywords

MetforminIncretin hormonesInflammationMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Change in GLP-1 (glucagon like peptide) and GIP (gastric inhibitory peptide) postprandial secretion

    The primary endpoint of the study is the change in postprandial GLP-1(ng/ml) and GIP (ng/ml) secretion with metformin treatment compared to placebo.

    4 months

Secondary Outcomes (9)

  • Change in glycemic variability pre- and post- treatment

    4 months

  • Metabolomic profile of each treatment group

    4 months

  • Change in inflammatory state

    4 months

  • Change in endothelial dysfunction

    4 months

  • Change in cytokine production

    4 months

  • +4 more secondary outcomes

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Patients will continue with their standard insulin therapy and will additionally receive orally metformin 2gr/day.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Patients will continue with their standard insulin therapy and will additionally receive placebo

Drug: Placebo

Interventions

MetforminDRUG

Participants will be randomized to metformin 2000 mg

Metformin
PlaceboDRUG

Participants will be randomized to placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year of diagnosis)
  • Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

You may not qualify if:

  • Any cardiovascular disease within the last 3 months
  • 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\<60 ml/min/1.73m2
  • Gastrointestinal disease or gastroparesis
  • Prior diagnosis of cancer within 2 years
  • Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticosteroids)
  • Untreated or uncontrolled thyroid disease
  • Pregnancy or breastfeeding
  • Alcohol consumption \> 2-drinks per day or other substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Center, 1st Internal Medicine Department, AHEPA University General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54636, Greece

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Inflammation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Kotsa Kalliopi, MD,PhD

    1st Internal Medicine Department, AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelos J Giamarellos-Bourboulis, MD, PhD

CONTACT

+306945521800egiamarel@med.uoa.gr

Antigoni J Kotsaki, MD,PhD

CONTACT

+306946637164antigonebut@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
All pills will be provided as effervescent, pre-scored 1000mg tablets, so that they may easily be dichotomized.Boxes with active drug or placebo will be covered to conceal the identity of the test article. Sponsor will provide covering materials.The unblinded designee will provide the covered boxes to the blinded nurse or blinded investigator who will dispense the pills.Participants will be given study drug diaries, which they will complete during study drug intake.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot, mechanistic, phase 3, randomized, placebo-controlled, parallel designed, double-blinded clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 26, 2019

Study Start

November 29, 2019

Primary Completion

November 29, 2022

Study Completion

November 29, 2022

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)