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 Overview
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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

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin 338 (GIPET I)
* Drug: insulin glargine
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose (FPG) |  | Week 0, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |