Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

Phase 2 Completed 50 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy

Timeline

Start: 2015-06-01
Primary completion: 2015-12-31
Completion: 2015-12-31

Publications

Results Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Morschel L. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):179-188. doi: 10.1016/S2213-8587(18)30372-3. Epub 2019 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin 338	Protein / enzyme biologic	—	Oral
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

Summary

Timeline

Publications

Drugs

Indications