Clinical trial NCT04027023: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sciema UG
Sponsor class: OTHER
Collaborators: name: Innovative Diabetes Treatment Studies LLC.
First posted: 2019-07-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, prospective, phase IV study
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: impact of a temporary personalized poly-pharmaceutical treatment on the disease stage in patients with type 2 diabetes
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c measurement to evaluate the impact of the poly-pharmaceutical treatment on the glycemic control
timeFrame: 12 weeks
measure: RBP4 will be measured to evaluate the impact of the poly-pharmaceutical treatment on the RBP4 level
timeFrame: 12 weeks
measure: the biomarker adiponectin will be measured to evaluate the impact of the poly-pharmaceutical treatment on the adiponectin level
timeFrame: 12 weeks
measure: insulin, c-peptide, intact proinsulin, glucagon will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on beta-cell function
timeFrame: 12 weeks
measure: hsCRP, IL-6, angiopoetin 2 will be measured to evaluate the impact of a temporary personalized poly-pharmaceutical treatment on biomarkers of inflammation
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: Renal function
timeFrame: 12 weeks
measure: Liver function
timeFrame: 12 weeks
measure: Heart function
timeFrame: 12 weeks
measure: Electrolytic balance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Research, Inc.
state: New York
city: Mainz
country: Germany
facility: Pfützner Science & Health Institute GmbH
state: Rhineland-Palatinate
Study officials:
References: