A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
NCT ID: NCT02148861
Last Updated: 2021-03-08
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
49 participants
INTERVENTIONAL
2014-05-26
2015-06-01
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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Insulin 287 + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
Insulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days
Insulin degludec + placebo
Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).
insulin degludec
Administered once-daily subcutaneously (s.c., under the skin) for 35 days
placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days
Interventions
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Insulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
insulin degludec
Administered once-daily subcutaneously (s.c., under the skin) for 35 days
placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of no childbearing potential \[if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L\]
* Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Exclusion Criteria
* Receipt of any investigational medicinal products within 3 months before screening
* Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
18 Years
64 Years
ALL
No
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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2013-001180-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1140-5344
Identifier Type: OTHER
Identifier Source: secondary_id
NN1436-4057
Identifier Type: -
Identifier Source: org_study_id
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