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Diabetes Mellitus, Type 2Phase 4NCT04027023

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

A Phase 4 study testing Diabetes mellitus Type 2 De-escalation treatment (DET) in people with Diabetes Mellitus, Type 2, run by Sciema UG at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Diabetes mellitus Type 2 De-escalation treatment (DET)
How many people
9 participants
Where
2 sitesin 2 countries
Study dates
30 Oct 2019to 31 May 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • NYC Research, Inc.

    New York, New York, 10001

Other trials in United States

Germany1 site

  • Pfützner Science & Health Institute GmbH

    Mainz, Rhineland-Palatinate, 55128

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Diabetes mellitus Type 2 De-escalation treatment (DET)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

    1. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    combined drug application

    Measured: 12 weeks

Secondary outcomes (10)

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

    venous blood draw to evaluate the HbA1c

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  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

    blood draw to measure the above mentioned biomarkers

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

  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

    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.

    Measured: 12 weeks

  7. 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

    Measured: 12 weeks

  8. 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

    Measured: 12 weeks

  9. 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

    Measured: 12 weeks

  10. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start30 Oct 2019
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open-label, prospective, phase IV study
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04027023
Sponsor's protocol ID
DCTI-DET-001
Status last verified
Mar 2021
First submitted
11 Jul 2019
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diabetes mellitus Type 2 De-escalation treatment (DET) in people with Diabetes Mellitus, Type 2, run by Sciema UG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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