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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02148861
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Diabetes Mellitus Drug: Insulin icodec Drug: insulin degludec Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
Actual Study Start Date : May 26, 2014
Actual Primary Completion Date : June 1, 2015
Actual Study Completion Date : June 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: Insulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
Other Name: insulin 287

Drug: placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days

Active Comparator: 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).
Drug: insulin degludec
Administered once-daily subcutaneously (s.c., under the skin) for 35 days

Drug: placebo
Administered subcutaneously (s.c., under the skin) once-daily for 35 days




Primary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65) ]

Secondary Outcome Measures :
  1. Area under the steady-state serum insulin 287 concentration-time curve [ Time Frame: During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29) ]
  2. area under the glucose infusion rate - time curve at steady-state [ Time Frame: At Day 31 and day 35 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent
  • 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:

  • Known or suspected hypersensitivity to trial products or related products
  • 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

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): NCT02148861


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02148861    
Other Study ID Numbers: NN1436-4057
2013-001180-22 ( EudraCT Number )
U1111-1140-5344 ( Other Identifier: WHO )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs