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Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01002768
First received: October 26, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes

October 26, 2009
June 29, 2012
October 2009
March 2010   (final data collection date for primary outcome measure)
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration [ Time Frame: within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01002768 on ClinicalTrials.gov Archive Site
  • Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose [ Time Frame: within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Time from start of hypoglycaemic induction until each level of plasma glucose is reached [ Time Frame: within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L [ Time Frame: within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Hypoglycaemic symptoms score during recovery from hypoglycaemia [ Time Frame: within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
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 1
  • Drug: NN1250
    Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
  • Drug: insulin glargine
    Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
  • Experimental: A
    Intervention: Drug: NN1250
  • Active Comparator: B
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Body mass index (BMI): 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • Use of insulin glargine within 3 months prior to trial entry
  • 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
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01002768
NN1250-3538, U1111-1111-8843, 2008-008356-16
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Carsten Roepstorff, 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