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Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01865292
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: insulin glargine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
Study Start Date : August 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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Arm Intervention/treatment
Experimental: Insulin degludec Drug: insulin degludec
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Active Comparator: Insulin glargine Drug: insulin glargine
Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.




Primary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: 0-24 hours after dosing ]

Secondary Outcome Measures :
  1. Area under the insulin degludec/insulin glargine curve [ Time Frame: 0-96 hours after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
  • Specific inclusion criteria for subject with type 1 diabetes:
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
  • Specific inclusion criteria for subject with type 2 diabetes:
  • Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
  • Treated with insulin for the past 3 months prior to screening
  • Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive)

Exclusion Criteria:

  • Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
  • Subject with a history of or presence of cancer
  • Any condition that the Investigator and/or Sponsor feels would interfere with study
  • Specific exclusion criteria for subject with type 2 diabetes:
  • Therapy with oral antidiabetic drugs within the past 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): NCT01865292


Locations
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Germany
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: NCT01865292     History of Changes
Other Study ID Numbers: NN5401-1719
2006-001915-31 ( EudraCT Number )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs