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

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin 338 (GIPET I); Drug: insulin glargine; Drug: placebo

• Registration Number: NCT02470039
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-29
• Study Start: 2015-06-01
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Disposition First Submitted: 2016-11-09
• Disposition First Submitted QC: 2016-11-09
• Disposition First Posted: 2016-11-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral insulin 338 and subcutaneous placebo	insulin 338 (GIPET I)	-
Oral insulin 338 and subcutaneous placebo	placebo	-
Subcutaneous insulin glargine and oral placebo	insulin glargine	-
Subcutaneous insulin glargine and oral placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose (FPG)	Week 0, Week 8

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany