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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
insulin 338 (GIPET I)
insulin glargine
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral insulin 338 and subcutaneous placebo

Subcutaneous insulin glargine and oral placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in fasting plasma glucose (FPG)

Secondary Outcome Measures

Change from baseline in 10-points plasma glucose profile
Number of treatment emergent hypoglycaemic episodes
area under the serum insulin concentration-time curve

Full Information

First Posted
May 29, 2015
Last Updated
March 13, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02470039
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral insulin 338 and subcutaneous placebo
Arm Type
Experimental
Arm Title
Subcutaneous insulin glargine and oral placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin 338 (GIPET I)
Intervention Description
Oral administered once daily in combination with metformin with or without DPP-4 inhibitor
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered once daily
Primary Outcome Measure Information:
Title
Change in fasting plasma glucose (FPG)
Time Frame
Week 0, Week 8
Secondary Outcome Measure Information:
Title
Change from baseline in 10-points plasma glucose profile
Time Frame
Week 0, Week 8
Title
Number of treatment emergent hypoglycaemic episodes
Time Frame
From start of treatment until Visit 14 (Day 68)
Title
area under the serum insulin concentration-time curve
Time Frame
During one dosing interval (0 to 24 hours) at steady state (Day 56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30679095
Citation
Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Morschel L. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):179-188. doi: 10.1016/S2213-8587(18)30372-3. Epub 2019 Jan 21.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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