DRKS00012330
Active, not recruiting
未知
Pilot study to evaluate the benefit and tolerability of PDM022616 on blood glucose levels in subjects with prediabetes - CEF/022616
Cefak KG0 sites25 target enrollmentApril 13, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- increased blood glucose/HbA1c/oGTT-levels
- Sponsor
- Cefak KG
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 25\-34\.9 kg/m2
- •\- HbA1c 5\.7\-6\.4% (39\-47 mmol/mol) at V1
- •\- Subject’s agreement to comply with study procedures
- •\- Stable concomitant medications (if any) for at least last 3 months prior to V1
- •and during the study
- •\- Stable body weight (\=3 kg difference) for the last 3 months prior to V1
- •\- Regular intake of three main meals (breakfast, lunch and dinner)
- •\- Women of childbearing potential:
- •a. negative pregnancy testing (beta human chorionic gonadotropin test in
- •urine) at V1
Exclusion Criteria
- •1\. Known sensitivity to the components of the investigational product
- •2\. Pathological electrocardiogram (ECG)
- •3\. Psychotic disorders within the last 6 months prior to V1
- •4\. History and/or presence of clinically significant disease, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •a. eating disorders such as anorexia
- •b. untreated or non\-stabilized thyroid disorder
- •c. untreated or non\-stabilized hypertension
- •d. significant gastrointestinal diseases
- •e. spleen disorder
- •f. known severe acute or chronic immunological disorders such as AIDS (or HIV positive)
Outcomes
Primary Outcomes
Not specified
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