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Completed

NCT Number: NCT02470039

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Mainz, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin 338 (GIPET I)

Drug

Oral administered once daily in combination with metformin with or without DPP-4 inhibitor

insulin glargine

Drug

Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor

Placebo

Drug

Administered once daily

Primary outcomes

  1. Change in fasting plasma glucose (FPG)

    Time frame: Week 0, Week 8

Secondary outcomes

  1. Change from baseline in 10-points plasma glucose profile

    Time frame: Week 0, Week 8

  2. Number of treatment emergent hypoglycaemic episodes

    Time frame: From start of treatment until Visit 14 (Day 68)

  3. area under the serum insulin concentration-time curve

    Time frame: During one dosing interval (0 to 24 hours) at steady state (Day 56)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2015
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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