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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568984
First Posted: December 6, 2007
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
December 4, 2007
December 6, 2007
February 20, 2017
November 21, 2002
November 10, 2003   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 16 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00568984 on ClinicalTrials.gov Archive Site
  • Glucose profiles
  • Quality of life assessment
  • Treatment satisfaction
  • Hypoglycaemic events
  • Adverse events
Same as current
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
Intervention Model: Parallel Assignment
Masking: None (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 10, 2003
November 10, 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Malaysia,   Philippines,   Thailand
 
 
NCT00568984
AGEE-3017
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