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

• Status: Completed
• Trial end date: 2015-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

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; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

Exclusion Criteria:

• Known or suspected hypersensitivity to the trial products or related products

• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator