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Also known as insulin 338 (GIPET I)
insulin 338 · 5 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Oral insulin 338 and subcutaneous placebo | EXPERIMENTAL | - |
| Subcutaneous insulin glargine and oral placebo | ACTIVE_COMPARATOR | - |
| Eating meal immediately after dosing | EXPERIMENTAL | - |
| Eating meal 30 min after dosing | EXPERIMENTAL | - |
| Eating meal 1 hour after dosing | EXPERIMENTAL | - |
| Eating meal 6 hour after dosing | EXPERIMENTAL | - |
| Part 1 insulin 338 | EXPERIMENTAL | - |
| Part 1 placebo | PLACEBO_COMPARATOR | - |
| Part 2 insulin 338 | EXPERIMENTAL | - |
| Part 2 insulin glargine | ACTIVE_COMPARATOR | - |
| Coating A | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Coating B | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Coating C | EXPERIMENTAL | Each subject will in random order be allocated to three single-dose administrations of insulin 338 in a GIPET® I tablet with 3 different coatings, respectively, on three separate dosing visits (Visits 2, 3 and 4). Each of the three dosing days will be separated by a 3-week wash-out period (ranging from 20 to 28 days) |
| Insulin 338 + placebo | EXPERIMENTAL | - |
| Insulin glargine + placebo | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| insulin 338 (GIPET I) | DRUG | Oral administered once daily in combination with metformin with or without DPP-4 inhibitor |
| insulin glargine | DRUG | Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor |
| placebo | DRUG | Administered once daily |
| Insulin 338 | DRUG | Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin). |
Inclusion Criteria: * Age of 18-70 years (both inclusive) at the time of signing informed consent * Body mass index of 25.0-40.0 kg/m\^2 (both inclusive) * Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening * Insulin naïve subject; howev...
Insulin 338 is an investigational oral insulin tablet developed by Novo Nordisk for the treatment of diabetes. It is a small molecule that acts as an agonist at the insulin receptor (INSR). The drug has completed Phase 2 clinical testing and is not approved for any indication.
Insulin 338 is being developed for the treatment of diabetes, including type 1 and type 2 diabetes. Clinical trials have evaluated it in tablet form for type 2 diabetes and as a subcutaneous formulation in type 1 diabetes. It remains an investigational therapy and is not approved for clinical use.
Insulin 338 is an agonist of the insulin receptor (INSR). By binding to and activating INSR, it mimics the action of endogenous insulin to promote glucose uptake and lower blood glucose levels. This mechanism underlies its development as an insulin replacement therapy for diabetes.
Insulin 338 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the New York Stock Exchange under the ticker NVO. Novo Nordisk conducted the clinical trials of the drug, including Phase 1 and Phase 2 studies in healthy volunteers and patients with diabetes.
Insulin 338 has completed Phase 2 clinical development. Five trials have been completed, including one Phase 2 study and four Phase 1 studies, with a total enrollment of 242 participants. The drug is investigational and has not been approved by the FDA.
Insulin 338 has been studied in five completed trials. The Phase 2 trial NCT02470039 compared the tablet formulation with insulin glargine in type 2 diabetes. Phase 1 trials include NCT02304627, NCT02220296, and NCT01931137, which evaluated pharmacokinetics, pharmacodynamics, and food effects in healthy subjects and patients with type 1 diabetes.
Yes, insulin 338 is also known as insulin 338 (GIPET I). GIPET I refers to the oral delivery technology used in its tablet formulation. Both names refer to the same investigational drug candidate developed by Novo Nordisk for diabetes.