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

• Status: Active, not recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sciema UG
• Collaborator: Innovative Diabetes Treatment Studies LLC.
• Treatments: Insulin

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)