Oromucosal Delivery of Insulin: “Proof of Concept” Using a Mucoadhesive Wafer Dosage Form Containing Insulin. A single-center study with two parts: Part 1 comparing lingual/palatal versus gingival insulin wafer administration according to an open-label, parallel-group design, and, on condition that satisfactory exposure has been achieved, Part 2 investigating positive and negative control according to a double blind, crossover design. PART 1

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000758

Enrollment

Registered

2011-07-12

Start date

2012-08-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a Phase I study, involving healthy subjects. The study is designed as a "Proof of Concept" to evaluate oromucosal delivery of insulin, contained in a mucoadhesive wafer. The study population in this clinical study will not benefit from the treatment. Orosomucosal delivery of insulin may be of benefit to patients with Diabetes Mellitus. E10

Interventions

Group 1: One of two wafers will be placed on the upper side of the tongue and the other wafer under the hard palate (lingual/palatal administration). This corresponds to a single dose of 150 IU insuli

N=6 healthy subjects. Group 2: One of the two wafers will be placed on the upper gum and the other wafer on the lower gum (gingival administration). This corresponds to a single dose of 150 IU insulin

N=6 healthy subjects.

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Male subjects of any ethnic origin between 18 and 45 years of age (inclusive); Non-smokers; In good general physical health, determined by medical history (including exclusion of first-degree family diabetes); Physical examination, electrocardiogram (ECG), vital signs, clinical laboratory tests; Body Mass Index within 19 to 28 kg/m2 and body weight within 69.4 to 80.6 kg (75 kg ± 7.5%); Fasting venous blood glucose between 70 and 110 mg/dL (inclusive).

Exclusion criteria

Exclusion criteria: Subjects with tendency for gum bleeding, oromucosal lesions or other oromucosal diseases; Subjects with a clinical history of allergic reactions against p-Hydroxy benzoic acid esters (PHB-esters); Hypersensitivity to any of the ingredients of the investigational medicinal product; Any history of alcohol or drug abuse; Any history of chronic gastritis or peptic ulcers; Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (esp. history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies and bleeding tendency; Blood donation within 30 days prior to inclusion in this study; Laboratory values outside the reference range that are of clinical relevance (e.g., suggesting an unknown disease and requiring further clinical evaluation assessed by the investigator) especially aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT).

Design outcomes

Primary

Measure	Time frame
Part 1 of the study: To compare insulin delivery after lingual/palatal application with gingival application of two insulin-containing wafers.	—

Secondary

Measure	Time frame
Secondary objective is to assess the safety and tolerability of oromucosal application of insulin containing wafers. Adverse events, physical examination, clinical laboratory, vital signs, ECG, local and overall tolerability.	—

Countries

Germany

Contacts

Public ContactWolfgang Timmer

CRS Clinical Research Services Mannheim GmbH

wolfgang.timmer@crs-group.de+49 621 15045 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026