NCT04027023

Brief Summary

This phase IV study is a prospective open-label multi-center study to investigate the effect of a temporary individualized poly-pharmaceutical De-escalation treatment with the target to regenerate ß-cell function over 12 weeks on the disease stage and glycemic control in patients with type 2 diabetes. This is an uncontrolled pilot study to collect data for later confirmatory trials.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2019

Geographic Reach
2 countries

2 active sites

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

July 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

July 11, 2019

Last Update Submit

March 30, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes

    combined drug application

    12 weeks

Secondary Outcomes (10)

  • HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control

    12 weeks

  • RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level

    12 weeks

  • the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level

    12 weeks

  • insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function

    12 weeks

  • hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation

    12 weeks

  • +5 more secondary outcomes

Interventions

Diabetes mellitus Type 2 De-escalation treatment (DET)DRUG

All employed drugs are approved in the US for treatment of type 2 diabetes and are used within their label. There will be defined individual treatment drug combinations at an earlier stage of diabetes as in standard treatment. The DET combination will be composed out of one each or more of the drugs and interventions listed below. A. Relieve for the insulin-producing ß-cells insulin glargine (6 to 20 U at bedtime) insulin degludec (5 to 15 U at bedtime) B. Reduction of hormonal visceral lipid tissue activity/chronic inflammation Weight loss liraglutide (0.6 mg/day) exenatide (15 µg/day) C. Treatment of metabolic and vascular insulin resistance Pioglitazone (30 mg) D. Treatment of glucose toxicity Empagliflozin (SGLT-II inhibitor; 10 mg) Dapagliflozin (SGLTII-Inhibitor, 10 mg) Canagliflozin (SGLT-II inhibitor, 100 mg) Metformin (inhibition of hepatic glucose production, 500 mg) To avoid hypos, all drugs are initially given in the lowest possible dose.

Eligibility Criteria

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

You may qualify if:

  • Informed consent obtained prior to any trial-related activities
  • Male or female \> 18 years
  • Diagnosed with 2 Diabetes
  • HbA1c \<10%
  • Current treatment with diet and exercise or up to two anti-diabetic drugs

You may not qualify if:

  • Patients participating in another investigational drug study
  • Drug or alcohol abuse
  • Pregnancy or breast feeding
  • Sexually active woman of childbearing age not practicing accepted birth control
  • Severe diabetes complications (in the discretion of investigator)
  • Unstable significant cardiovascular disease with admission to emergency room or hospital in last 45 days
  • Lack of compliance or other reason that in the discretion of the investigator precludes satisfactory participation in the study
  • Any severe illness preventing participation in the study per protocol (in the discretion of the investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYC Research, Inc.

New York, New York, 10001, United States

Location

Pfützner Science & Health Institute GmbH

Mainz, Rhineland-Palatinate, 55128, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open-label, prospective, phase IV study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 19, 2019

Study Start

October 30, 2019

Primary Completion

April 30, 2021

Study Completion

May 31, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)US(1)