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.

First Received: June 29, 2007 Last Updated: November 26, 2008 History of Changes

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, isophane Insulin aspart

U.S. FDA Resources

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

Secondary Outcome Measures:

blood glucose profiles
HbA1c

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

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:	ANA-1635
Study First Received:	June 29, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00494988 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
Insulin, Asp(B28)-
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
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin, Isophane
Insulin

ClinicalTrials.gov processed this record on March 16, 2009