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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470039
• Other study ID #: NN1953-4163
• Secondary ID: 2014-002716-16U1
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2015
• Est. completion date: December 31, 2015

Study information

• Verified date: March 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin 338 (GIPET I)
Oral administered once daily in combination with metformin with or without DPP-4 inhibitor
• insulin glargine
Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor
• placebo
Administered once daily

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Mörschel 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) — View Citation

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk