Completed

Safety and Effectiveness of NNC0123-0000-0338 in Type 2 Diabetes Patients

Study Aim

This phase 1 study aims to evaluate the safety and effectiveness of NNC0123-0000-0338 in individuals with Type 2 Diabetes, primarily focusing on the number of treatment-related adverse events.

What is being tested

insulin 338 (GIPET I)

+ placebo

+ insulin glargine

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 64 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2013

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: March 1, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: February 21, 2013

Actual date on which the first participant was enrolled.

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.

NCT01796366

Principal SponsorNovo Nordisk A/S

Last updated: March 1, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

3 inclusion criteria required to participate

Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)

Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)

Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

3 exclusion criteria prevent from participating

Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol

Known or suspected hypersensitivity to trial products or related products

Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Novo Nordisk Investigational Site

Neuss, GermanyOpen Novo Nordisk Investigational Site in Google Maps

CompletedOne Study Center