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Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

This study has been terminated.
(Low recruitment status)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00799448
First Posted: November 27, 2008
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
November 26, 2008
November 27, 2008
February 20, 2017
September 16, 2003
September 20, 2004   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 20 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00799448 on ClinicalTrials.gov Archive Site
  • Fasting blood glucose (FBG)
  • Incidence of hypoglycaemic episodes
  • Adverse events
Same as current
Not Provided
Not Provided
 
Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes
Multi-centre, Open, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled With SU +/ Biguanide Therapy, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin vs. Insulin Alone
This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: repaglinide
  • Drug: biphasic human insulin 30
  • 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.
 
Terminated
40
September 20, 2004
September 20, 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c: 7.5-11.0% on current therapy
  • OHA (oral hypoglycaemic agent) treatment for a minimum of two years
  • BMI (body mass index): 25-32 kg/m2
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00799448
AGEE-1524
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
February 2017

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