A trial comparing NNC0123-0000-0338 in a tablet formulation and insulin glargine in subjects with type 2 diabetes currently treated with oral antidiabetic therapy

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 17.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-002716-16-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-11
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female subject
2. Age of 18–70 years (both inclusive) at the time of signing informed consent
3. Body mass index of 25.0–40.0 kg/m^2 (both inclusive)
4. Subject diagnosed (clinically) with type 2 diabetes mellitus for =180 days prior to the day of screening
5. 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Known or suspected hypersensitivity to the trial products or related products
2. Any disorder which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
3. Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified