Clinical Study to Assess the Impact of a Bacterial- and Yeast-based Nutritional Supplement (SugarBurner) on Glucose Control in Patients with Type 2 Diabetes mellitus

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00023745
• Lead Sponsor: Sugarburner AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-27
• Study Start: 2020-12-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1.age > 18 years
2. diagnosed type 2 diabetes mellitus
3. HbA1c value within the last 2 months before screening visit > 6.0% and < 9.9%
4. receiving one or a combination of the following antidiabetic treatments:
• lifestyle only (diet and exercise)
• oral antidiabetic treatment
• GLP1-analogs
• insulin treatment

Exclusion Criteria

1. Diabetes mellitus type 1
2. Acute or chronic gastrointestinal disease
3. Anemia
4. Acute hyperthyreosis (TSH value not within normal range)
5. History of severe or multiple allergies
6. Known allergy against probiotic nutritional supplements
7. Participation in a clinical trial within 3 months before trial entry.
8. Progressive fatal diseases
9. Drug or alcohol abuse within the last 5 years
10. Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective is the evaluation of the impact of SugarBurner on glycemic control (time in normoglycemia) as compared to placebo and as assessed by continuous glucose measurement by means of the Freestyle Libre 2 device after 2, 4, and 6 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of the dietary supplement in comparison to placebo on:<br>• HbA1c<br>• Lipids<br>• Uric acid<br>• Insulin Sensitivity as assessed by HOMA Score<br>• ß-cell function as assessed by fasting intact proinsulin values<br>• cardiovascular risk / inflammatory status as assessed by hsCRP<br>• tolerability of the supplement (type and number of adverse events)