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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oral insulin 338 and subcutaneous placebo

Group Type EXPERIMENTAL

insulin 338 (GIPET I)

Intervention Type DRUG

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

placebo

Intervention Type DRUG

Administered once daily

Subcutaneous insulin glargine and oral placebo

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

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

placebo

Intervention Type DRUG

Administered once daily

Interventions

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insulin 338 (GIPET I)

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

Intervention Type DRUG

insulin glargine

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

Intervention Type DRUG

placebo

Administered once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No