Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00568984
First received: December 4, 2007
Last updated: June 5, 2012
Last verified: January 2012

December 4, 2007
June 5, 2012
November 2002
November 2003   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 16 weeks of treatment ]
Complete list of historical versions of study NCT00568984 on ClinicalTrials.gov Archive Site
  • glucose profiles [ Designated as safety issue: No ]
  • Quality of life assessment [ Designated as safety issue: No ]
  • Treatment satisfaction [ Designated as safety issue: No ]
  • Hypoglycaemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • glucose profiles
  • Quality of life assessment
  • Treatment satisfaction
  • Hypoglycaemic events
  • Adverse events
Not Provided
Not Provided
 
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes

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: metformin
  • Drug: glicazide
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
324
November 2003
November 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 3 months
  • No previous treatment for diabetes
  • HbA1c between 7.0-12.0%
  • Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria:

  • Type 1 diabetes
  • Known unstable/untreated proliferative retinopathy
  • Uncontrolled treated/untreated hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Malaysia,   Philippines,   Thailand
 
NCT00568984
AGEE-3017
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Jing Ping Yeo Novo Nordisk Asia Pacific Pte.
Novo Nordisk A/S
January 2012

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