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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

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 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
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

Additional Information:
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