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Trial record 8 of 544 for:    INSULIN ASPART

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02933853
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Faster-acting insulin aspart Drug: Insulin Aspart Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : October 14, 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Faster Aspart Drug: Faster-acting insulin aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.

Active Comparator: Insulin Aspart Drug: Insulin Aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.




Primary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 30 minutes ]

Secondary Outcome Measures :
  1. Maximum observed serum insulin aspart concentration [ Time Frame: Within 0 to 12 hours after dosing ]
  2. Area under the glucose infusion rate curve [ Time Frame: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing) ]
  3. Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 18−75 years (both inclusive) at the time of signing informed consent. The total number of subjects aged 65−75 years (both inclusive) must NOT exceed 25.
  • Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening
  • HbA1C below or equal to 9.5 % based on central laboratory analysis

Exclusion Criteria:

  • Smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days 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): NCT02933853


Locations
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Austria
Novo Nordisk Investigational Site
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02933853     History of Changes
Other Study ID Numbers: NN1218-4265
2016-000200-28 ( EudraCT Number )
U1111-1178-3964 ( Other Identifier: WHO )
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs