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

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ClinicalTrials.gov Identifier: NCT04027023
Recruitment Status : Active, not recruiting
First Posted : July 19, 2019
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Innovative Diabetes Treatment Studies LLC.
Information provided by (Responsible Party):
Sciema UG

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Diabetes mellitus Type 2 De-escalation treatment (DET) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, prospective, phase IV study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Diabetes mellitus Type 2 De-escalation treatment (DET)

    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 Measures :
  1. impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes [ Time Frame: 12 weeks ]
    combined drug application


Secondary Outcome Measures :
  1. HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control [ Time Frame: 12 weeks ]
    venous blood draw to evaluate the HbA1c

  2. RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level [ Time Frame: 12 weeks ]
    blood draw to measure the above mentioned biomarker

  3. the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level [ Time Frame: 12 weeks ]
    blood draw to measure the above mentioned biomarker

  4. insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function [ Time Frame: 12 weeks ]
    blood draw to measure the above mentioned biomarkers

  5. hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation [ Time Frame: 12 weeks ]
    blood draw to measure the above mentioned biomarkers

  6. 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 [ Time Frame: 12 weeks ]
    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.

  7. Renal function [ Time Frame: 12 weeks ]
    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

  8. Liver function [ Time Frame: 12 weeks ]
    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

  9. Heart function [ Time Frame: 12 weeks ]
    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

  10. Electrolytic balance [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027023


Locations
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United States, New York
NYC Research, Inc.
New York, New York, United States, 10001
Germany
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany, 55128
Sponsors and Collaborators
Sciema UG
Innovative Diabetes Treatment Studies LLC.
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Responsible Party: Sciema UG
ClinicalTrials.gov Identifier: NCT04027023    
Other Study ID Numbers: DCTI-DET-001
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases