Oral Formulation of Insulin for Preterm Infants

Elgan Pharma

Status and phase: Terminated; Phase 2

Conditions: Premature Birth of Newborn

Treatments: Biological: Placebo; Biological: Oral Formulation of Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093638

CTILYAB004409LND10LaniadoH

Details and patient eligibility

About

The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

Full description

The study will aim to determine whether an oral formulation of insulin administration enhances gastrointestinal maturation. The gastrointestinal maturation will be evaluated by the ability of premature infants to achieve complete enteral feeds. The insulin concentration administered in the study is physiological and within the insulin concentration range present in human breast milk and colostrum.

Enrollment: 33 patients

Sex: All

Ages: 26 to 33 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Pre-term infants 26-33 weeks gestation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

Oral Formulation of Insulin

Experimental group

Description:

Oral formulation of insulin fed concomitantly with premature infant formula

Treatment:

Biological: Oral Formulation of Insulin

Oral Formulation of Placebo

Placebo Comparator group

Description:

Oral formulation of placebo fed concomitantly with premature infant formula

Treatment:

Biological: Placebo