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

March 13, 2019 updated by: Novo Nordisk A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55116
        • Novo Nordisk Investigational Site
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: placebo
Administered once daily
Drug: insulin glargine
Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1953-4163
  • 2014-002716-16 (EudraCT Number)
  • U1111-1158-3620 (Other Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on insulin 338 (GIPET I)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe