Status:
UNKNOWN
Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Sciema UG
Collaborating Sponsors:
Innovative Diabetes Treatment Studies LLC.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-c...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04027023
Start Date
October 30 2019
End Date
May 31 2021
Last Update
April 1 2021
Active Locations (2)
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1
NYC Research, Inc.
New York, New York, United States, 10001
2
Pfützner Science & Health Institute GmbH
Mainz, Rhineland-Palatinate, Germany, 55128