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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
ClinicalTrials.gov Identifier:
NCT01154881
First received: June 30, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the blood glucose-lowering effect of NN1250 in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: NN1250
 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 454 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: A Drug: NN1250
NN1250 injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject will be randomly allocated to 2 out of 4 treatments.
Experimental: B Drug: NN1250
NN1250 injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject will be randomly allocated to 2 out of 4 treatments.
Experimental: C Drug: NN1250
NN1250 injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject will be randomly allocated to 2 out of 4 treatments.
Experimental: D Drug: NN1250
NN1250 injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject will be 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 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 trial entry
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154881

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
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: June 29, 2012
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

ClinicalTrials.gov processed this record on May 16, 2013