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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02470039

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin 338 (GIPET I) Drug: insulin glargine Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral insulin 338 and subcutaneous placebo	Drug: insulin 338 (GIPET I) Oral administered once daily in combination with metformin with or without DPP-4 inhibitor Drug: placebo Administered once daily
Active Comparator: Subcutaneous insulin glargine and oral placebo	Drug: insulin glargine Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor Drug: placebo Administered once daily

Arm

Intervention/Treatment

Experimental: Oral insulin 338 and subcutaneous placebo

Drug: insulin 338 (GIPET I)

Oral administered once daily in combination with metformin with or without DPP-4 inhibitor

Drug: placebo

Administered once daily

Active Comparator: Subcutaneous insulin glargine and oral placebo

Drug: insulin glargine

Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor

Drug: placebo

Administered once daily

Outcome Measures

Primary Outcome Measures

Change in fasting plasma glucose (FPG) [Week 0, Week 8]

Secondary Outcome Measures

Change from baseline in 10-points plasma glucose profile [Week 0, Week 8]
Number of treatment emergent hypoglycaemic episodes [From start of treatment until Visit 14 (Day 68)]
area under the serum insulin concentration-time curve [During one dosing interval (0 to 24 hours) at steady state (Day 56)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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