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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00799448
First received: November 26, 2008
Last updated: March 6, 2013
Last verified: March 2013

November 26, 2008
March 6, 2013
September 2003
September 2004   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 20 weeks of treatment ]
Complete list of historical versions of study NCT00799448 on ClinicalTrials.gov Archive Site
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • fasting blood glucose (FBG)
  • incidence of hypoglycaemic episodes
  • adverse events
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 2004
September 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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00799448
AGEE-1524
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: A. Tigga Novo Nordisk Hellas Ltd.
Novo Nordisk A/S
March 2013

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