Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00383877

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 Mellitus, Type 2	Drug: insulin detemir Drug: insulin NPH	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

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 ]

Estimated Enrollment:	250
Study Start Date:	September 2006

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

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

Locations

China

Beijing, China

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Han Lijun	Pharmaceuticals Co., Ltd.
Study Director:	Cheng Yuwei	Pharmaceuticals Co., Ltd.

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1684
Study First Received:	October 3, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00383877 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009