Intestinimonas for Prevention of Type 2 Diabetes Mellitus

Caelus Pharmaceuticals

Status: Completed

Conditions: PreDiabetes

Treatments: Dietary Supplement: Placebo-capsules; Dietary Supplement: Intestinimonas-capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04495972

DM Prevent POC

Details and patient eligibility

About

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Full description

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes.

Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine.

In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota.

The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.

The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes.

The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• increased BMI > 25,
• Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose > 140 after OGTT, or HbA1c 5.7% - 6.4%

Exclusion criteria

• Type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Experimental arm: Intestinimonas

Active Comparator group

Description:

Intestinimonas in capsules

Treatment:

Dietary Supplement: Intestinimonas-capsules

Placebo arm: Placebo

Placebo Comparator group

Description:

Placebo in capsules

Treatment:

Dietary Supplement: Placebo-capsules