Pilot study to evaluate the benefit and tolerability of PDM022616 on blood glucose levels in subjects with prediabetes
- Conditions
- increased blood glucose/HbA1c/oGTT-levels
- Registration Number
- DRKS00012330
- Lead Sponsor
- Cefak KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 25
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
b. commitment to use contraception methods during the study
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)
g. severe acute or chronic infection
h. any other known significant or serious condition/disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to V1, any clinically significant cardiovascular, renal, liver, lung disease
etc.)
5. Clinical symptoms of diabetes type 2
6. Suspected diabetes type 1
7. Known congenital disorders of glycosylation
8. Known polycystic ovarian syndrome (female subjects)
9. Use of drugs/supplements which could interfere with the results of the study as per investigator's judgement (e.g. anti-diabetic therapy, products for reduction of blood glucose levels, products with a possible impact on glycemic control) within the last month prior to V1 and during the study
10. Blood transfusion within the last 12 weeks before V1
11. Blood donation within the last 6 month before V1
12. Previously known hemoglobinopathy (HbS, HbC, HbD, HbH, HbF or HbE)
13. Anemia (Hb =11 g/dL)
14. Recent change in diet and lifestyle (within the last 4 weeks prior to V1)
15. Deviation of safety laboratory parameter(s) at V1 (except for Hb and HbA1c) that is:
a. clinically significant or
b. >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
16. History of or current abuse of drugs, alcohol or medication in the last 6 months prior to V1
17. Participation in another study during the last 30 days prior to V1 and during the study
18. Women of child-bearing potential: pregnant or breast-feeding
18. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method blood sample: HbA1c at all visits, lab analysis
- Secondary Outcome Measures
Name Time Method blood sample: blood Glucose, oGTT, Insulin - all visits, lab Analysis; crp - begin and end, lab Analysis.<br>Further parameter: Body weight, waist circumference, blood pressure.