A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
NCT ID: NCT01028404
Last Updated: 2017-07-25
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
2009-11-30
2010-06-30
Brief Summary
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The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.
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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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Trial part 1
NN1952
Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
placebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
Trial part 2
NN1952
Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.
insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
placebo
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
Interventions
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NN1952
Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.
insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
placebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
NN1952
Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.
insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
placebo
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
Eligibility Criteria
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Inclusion Criteria
* Gender: male
* Age: 18-55 years
* BMI (body mass index): 18-28 kg/m2
* Study participants considered to be healthy
* FOR TRIAL PART 2, THE FOLLOWING APPLIES:
* Gender: male or female of no childbearing potential
* Age: 18-65 years
* Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
* Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
* Type 1 or type 2 diabetes for at least 12 months
* Type 1 diabetes: Treatment with insulin for at least 12 months
* Type 2 diabetes: Treatment with insulin for at least 3 months
Exclusion Criteria
* Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
* Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)
18 Years
55 Years
ALL
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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U1111-1112-2892
Identifier Type: OTHER
Identifier Source: secondary_id
2009-013282-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN1952-3646
Identifier Type: -
Identifier Source: org_study_id
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