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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00383877
First received: October 3, 2006
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FBG [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: during 20 weeks treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: September 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383877

Locations
China
Beijing, China
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Han Lijun Pharmaceuticals Co., Ltd.
Study Director: Cheng Yuwei Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00383877     History of Changes
Other Study ID Numbers: NN304-1684
Study First Received: October 3, 2006
Last Updated: June 26, 2012
Health Authority: China: Food and Drug Administration

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, Isophane
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014