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Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00383877
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin NPH Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Study Start Date : September 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 20 weeks of treatment ]

Secondary Outcome Measures :
  1. FBG [ Time Frame: after 20 weeks of treatment ]
  2. Safety profile [ Time Frame: during 20 weeks treatment ]
  3. Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: after 20 weeks of treatment ]
  4. Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial [ Time Frame: before breakfast during the trial at the end of the trial ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1C greater than 7.5% and less than or equal to 11.0%
  • Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion Criteria:

  • Previous acute treatment with insulin for more than 7 days.
  • Treatment with OAD(s) which does not adhere to the approval labeling.
  • Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383877


Locations
China
Beijing, China
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00383877     History of Changes
Other Study ID Numbers: NN304-1684
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
 Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs