A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
NCT ID: NCT01809184
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2013-03-04
2013-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose level 1
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 2
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 3
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 4
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 5
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 6
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Dose level 7
Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Interventions
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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.
insulin glargine
Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placebo
Oral placebo adminstered corresponding to insulin 287 treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-003048-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1132-1018
Identifier Type: OTHER
Identifier Source: secondary_id
NN1956-4014
Identifier Type: -
Identifier Source: org_study_id
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