Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus

Pilot Study for Evaluation of the Impact of Intensive Short-Term Drug Therapy on Beta-Cell Function and Insulin Resistance in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Diabetes mellitus Type 2 De-escalation treatment (DET)

Detailed Description

During the screening visit the patient will arrive at the study site and written informed consent will be obtained by the investigator. Inclusion and exclusion criteria will be controlled and blood will be drawn for HbA1c, the efficacy and the safety parameters. A POCT pregnancy test will be conducted in women of childbearing age. Patient demographics and history will be collect and a physical examination will be performed. The patient will complete a QoL questionnaire and will receive training about the de-escalation therapy approach. After all necessary biomarker results of the screening visit are accessible for the selection of the De-escalation treatment the treatment initiation visit will be performed. During this visit the investigator will use these results to determine a most optimal personalized treatment combination for regeneration of the pancreatic ß-cells within the next three months. An ECG will be recorded and the patient will be informed about his/her personalized treatment and its execution. The patient will receive the drugs in the volume required until the next visit. During the next two visits the patient will arrive at the investigational site at the agreed time-point and information regarding potential adverse events will be collected. Vital signs will be measured, and blood will be drawn for assessment of the efficacy parameters. Information about hypoglycaemia will be collected, and the patient will receive drug supply that lasts until the next visit. The patient will be instructed to stop the anti-diabetic medication 3 days before the next visit.

For the final visit (visit 5) the patient will arrive at the investigational site after an overnight fast and information regarding potential adverse events and hypoglycaemic events will be collected. Vital signs will be measured, and blood will be drawn for assessment of the efficacy parameters. An oral glucose challenge with 75 g of glucose will be conducted with blood draws for assessment of glucose and other biomarkers at time-points 0, 1h and 2h. The investigator will give a recommendation for the consecutive follow-up treatment requirements based on the results of the glucose challenge test. The patient will complete a QoL questionnaire (DTSQ) and this concludes study participation for the patient.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55128
      • Pfützner Science & Health Institute GmbH
• United States
  • New York
    • New York, New York, United States, 10001
      • NYC Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes	combined drug application	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control	venous blood draw to evaluate the HbA1c	12 weeks
RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level	blood draw to measure the above mentioned biomarker	12 weeks
the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level	blood draw to measure the above mentioned biomarker	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	blood draw to measure the above mentioned biomarkers	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	blood draw to measure the above mentioned biomarkers	12 weeks
Questionnaire about the diabetes treatment satisfaction (DTSQ) will be filled by the patient to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on the quality of Life	Questionnaire to be filled by study participant, the scale of the questionnaire reaches from 1 (very good) to 10 (very bad), all questions are bloning to the diabetes treatment.	12 weeks
Renal function	blood draw and urine sample to measure renal function, which will be evaluated with the following parameters creatinine, GFR, total protein (serum and urine), Uric acid and urea before and after the temporary personalized poly-pharmaceutical treatment	12 weeks
Liver function	blood draw to measure Liver function, which will be evaluated with the following parameters AST, ALT, gamma-GT, and alkaline phosphatase before and after the temporary personalized poly-pharmaceutical treatment	12 weeks
Heart function	blood draw to measure Heart function, which will be evaluated with the following parameters creatine kinase, and cK-MB before and after the temporary personalized poly-pharmaceutical treatment	12 weeks
Electrolytic balance	blood draw to measure Electrolytic balance, which will be evaluated with the following parameters: sodium, potassium and calcium before and after the temporary personalized poly-pharmaceutical treatment	12 weeks

Collaborators and Investigators

• Sponsor: Sciema UG
• Collaborators: Innovative Diabetes Treatment Studies LLC.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2019
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): May 31, 2021

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DCTI-DET-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No