Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01498926
First received: December 21, 2011
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.


Condition Intervention Phase
Diabetes
Healthy
Drug: insulin detemir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the serum insulin detemir concentration curve [ Designated as safety issue: No ]
  • Maximum serum insulin concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve [ Designated as safety issue: No ]
  • Time to maximum serum insulin concentration [ Designated as safety issue: No ]
  • Terminal serum insulin half life [ Designated as safety issue: No ]
  • Area under the serum insulin detemir concentration curve [ Designated as safety issue: No ]
  • Maximum glucose infusion rate [ Designated as safety issue: No ]
  • Time to maximum glucose infusion rate [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glycerol Drug: insulin detemir
Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
Active Comparator: Mannitol Drug: insulin detemir
Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
  • Non-smoker
  • Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria:

  • Known or suspected allergy to trial products or related products
  • Previous participation in this trial
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
  • The receipt of any investigational drug within the last 3 months prior to this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498926

Locations
United Kingdom
Manchester, United Kingdom, M15 6SH
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte B. Damholt Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01498926     History of Changes
Other Study ID Numbers: NN304-1685, 2005-002481-11
Study First Received: December 21, 2011
Last Updated: December 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014