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

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: insulin glargine

Drug: insulin 338 (GIPET I)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02470039

NN1953-4163

2014-002716-16 (EudraCT Number)

U1111-1158-3620 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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