Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Within-subject Variability of Insulin Detemir in Healthy Volunteers

NCT01497535

Diabetes Healthy

COMPLETED PHASE1

Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes

NCT00506662

Diabetes Diabetes Mellitus, Type 2

TERMINATED PHASE4

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

NCT01809184

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE1

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT00909480

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

NCT00604396

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glycerol

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Mannitol

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin detemir

Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Intervention Type DRUG

insulin detemir

Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
* Non-smoker
* Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria

* Known or suspected allergy to trial products or related products
* Previous participation in this trial
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
* The receipt of any investigational drug within the last 3 months prior to this trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No