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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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00494988
First received: June 29, 2007
Last updated: March 3, 2016
Last verified: March 2016

June 29, 2007
March 3, 2016
December 2004
April 2006   (final data collection date for primary outcome measure)
Remission rate [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Remission rate [ Time Frame: after 24 weeks ]
Complete list of historical versions of study NCT00494988 on ClinicalTrials.gov Archive Site
  • blood glucose profiles [ Designated as safety issue: No ]
  • HbA1c [ Designated as safety issue: No ]
  • blood glucose profiles
  • HbA1c
Not Provided
Not Provided
 
Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart
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
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin aspart
  • Drug: insulin NPH
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00494988
ANA-1635
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP