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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Diabetes mellitus Type 2 De-escalation treatment (DET)
Sponsored by
Sciema UG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYC Research, Inc.
  • Pfützner Science & Health Institute GmbH

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control
venous blood draw to evaluate the HbA1c
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
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
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
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
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.
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
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
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
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

Full Information

First Posted
July 11, 2019
Last Updated
March 30, 2021
Sponsor
Sciema UG
Collaborators
Innovative Diabetes Treatment Studies LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT04027023
Brief Title
Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciema UG
Collaborators
Innovative Diabetes Treatment Studies LLC.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open-label, prospective, phase IV study
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Diabetes mellitus Type 2 De-escalation treatment (DET)
Intervention Description
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.
Primary Outcome Measure Information:
Title
impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes
Description
combined drug application
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control
Description
venous blood draw to evaluate the HbA1c
Time Frame
12 weeks
Title
RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level
Description
blood draw to measure the above mentioned biomarker
Time Frame
12 weeks
Title
the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level
Description
blood draw to measure the above mentioned biomarker
Time Frame
12 weeks
Title
insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function
Description
blood draw to measure the above mentioned biomarkers
Time Frame
12 weeks
Title
hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation
Description
blood draw to measure the above mentioned biomarkers
Time Frame
12 weeks
Title
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
Description
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.
Time Frame
12 weeks
Title
Renal function
Description
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
Time Frame
12 weeks
Title
Liver function
Description
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
Time Frame
12 weeks
Title
Heart function
Description
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
Time Frame
12 weeks
Title
Electrolytic balance
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
NYC Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Pfützner Science & Health Institute GmbH
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
55128
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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