A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01154881
First received: June 30, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the glucose infusion rate curve from 0-24 hours at steady state [ Time Frame: 0-24 hours (derived on treatment day 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the insulin degludec concentration-time curve from 0-24 hours at steady state [ Time Frame: 0-24 hours (derived on treatment day 6) ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg 100U/mL 0.4U/kg Drug: insulin degludec
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
Experimental: IDeg 100U/mL 0.6U/kg Drug: insulin degludec
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
Experimental: IDeg 100U/mL 0.8U/kg Drug: insulin degludec
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
Experimental: IDeg 200U/mL 0.6U/kg Drug: insulin degludec
Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index (BMI) below or equal to 35.0 kg/m2

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
  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: NCT01154881

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hanne Hastrup-Nielsen, MSc., PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01154881     History of Changes
Other Study ID Numbers: NN1250-1987, U1111-1114-9099, 2009-017281-23
Study First Received: June 30, 2010
Last Updated: October 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014