Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01809184
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin 287 Drug: insulin glargine Drug: placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Actual Study Start Date : March 4, 2013
Actual Primary Completion Date : September 6, 2013
Actual Study Completion Date : September 6, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment

Experimental: Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Drug: insulin 287
Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Drug: insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Drug: placebo
Oral placebo adminstered corresponding to insulin 287 treatment




Primary Outcome Measures :
  1. Number of adverse events (AEs) [ Time Frame: As recorded from trial product administration and until completion of Sub-visit 2G (Day 13) ]

Secondary Outcome Measures :
  1. Area under the serum insulin concentration-time curve [ Time Frame: From 0 to 648 hours after a single dose ]
  2. Area under the glucose infusion rate (GIR)-time curve [ Time Frame: From 0 to 24 hours after a single dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index 18.0-28.0 kg/m^2
  • Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products
  • Previous participation in this trial. Participation is defined as randomised
  • 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
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809184


Locations
Layout table for location information
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01809184     History of Changes
Other Study ID Numbers: NN1956-4014
2012-003048-66 ( EudraCT Number )
U1111-1132-1018 ( Other Identifier: WHO )
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs