Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus
Status unconfirmed · Phase 4
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT04027023
- Run by
- Sciema UG
- People needed
- 9
- Starts
- 2019-10-30
- Expected to finish
- 2021-05-31
- Last updated by the study team
- 2021-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- NYC Research, Inc. — New York, New York, United States
- Pfützner Science & Health Institute GmbH — Mainz, Rhineland-Palatinate, Germany
Full record on ClinicalTrials.gov
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