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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

June 30, 2010
June 29, 2012
June 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01154881 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
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: A
    Intervention: Drug: NN1250
  • Experimental: B
    Intervention: Drug: NN1250
  • Experimental: C
    Intervention: Drug: NN1250
  • Experimental: D
    Intervention: Drug: NN1250
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01154881
NN1250-1987, U1111-1114-9099, 2009-017281-23
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Hanne Hastrup-Nielsen, MSc., PhD Novo Nordisk
Novo Nordisk
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP