Self-Control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart - Full Text View

Self-Control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00494988

Purpose

This trial is conducted in Asia.

The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin aspart Drug: insulin NPH	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin aspart Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Self-Control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-Term Intensive Insulin Aspart and Insulin NPH Treatment

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Remission rate [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood glucose profiles [ Designated as safety issue: No ]
HbA1c [ Designated as safety issue: No ]

Estimated Enrollment:	113
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes newly diagnosed within 6-12 months
FBG: 11.1-17.0 mmol/L
Body mass index (BMI) larger than 25.0 kg/m2

Exclusion Criteria:

Known or suspected allergy to trial product(s) or related products
Recurrent major hypoglycaemia as judged by the Investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494988

Locations


China, P. R. China

	Beijing, P. R. China, China, 100029

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Feng Yi	Novo Nordisk

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-1635
First Received:	June 29, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00494988
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Insulin, Asp(B28)-

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin, Isophane

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008