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Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00841087
First received: February 10, 2009
Last updated: November 9, 2009
Last verified: October 2009
History of Changes
  Purpose

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to NN1250 on a basal-bolus regimen in subjects with type 1 diabetes mellitus


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: insulin aspart
Drug: NN1250
Drug: insulin detemir
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety (With Emphasis on Hypoglycaemia) Comparison of NN1250 Versus Insulin Detemir All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus After 6 Weeks of Treatment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • The incidence of hypoglycaemic episodes during the 6 weeks of treatment [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • body weight [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: No ]
  • 12-lead ECG [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: during the 6 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: insulin aspart
Injection subcutaneously immediately before each meal.
Other Name: NovoRapid®
Drug: NN1250
Injection subcutaneously at bedtime
Active Comparator: B Drug: insulin aspart
Injection subcutaneously immediately before each meal.
Other Name: NovoRapid®
Drug: insulin detemir
Injection subcutaneously at bedtime
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 1 diabetes mellitus more than one year
  • Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only at least 12 weeks, using a long-acting insulin analogue or intermediate-acting insulin as a basal insulin and insulin aspart as bolus insulin
  • HbA1C below 10.0%

Exclusion Criteria:

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with total insulin dose of more than 100 U or IU/day
  • Current treatment or expected to start treatment with systemic corticosteroid
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841087

Locations
Japan
Chiyoda-ku, Tokyo, Japan, Japan, 100 0005
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Michiaki Kanai Novo Nordisk Pharma Ltd.
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00841087     History of Changes
Other Study ID Numbers: NN1250-3569, JAPIC: JapicCTI-090711
Study First Received: February 10, 2009
Last Updated: November 9, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013