Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01465152
First received: October 31, 2011
Last updated: November 3, 2011
Last verified: November 2011

October 31, 2011
November 3, 2011
March 2002
October 2004   (final data collection date for primary outcome measure)
Change of % HbA1c (glycosylated haemoglobin) in blood [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465152 on ClinicalTrials.gov Archive Site
  • Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres [ Designated as safety issue: No ]
  • Incidence of clinical and/or biochemistry hypoglycaemia episodes [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]
  • Presence of laboratory abnormalities in routine blood analyses [ Designated as safety issue: No ]
  • Change of the blood pressure and/or heart rate [ Designated as safety issue: No ]
  • Treatment compliance [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.

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: metformin
    Adminstered orally during the three main meals for 24 weeks
  • Drug: repaglinide
    Administered orally before the three main meals for 24 weeks
  • Experimental: Met
    Intervention: Drug: metformin
  • Active Comparator: Rep
    Intervention: Drug: repaglinide
  • Active Comparator: Met+Rep
    Interventions:
    • Drug: metformin
    • Drug: repaglinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
October 2004
October 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Treated by diet for at least 3 months
  • Never treated with hypoglycaemic drugs
  • HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria:

  • Very symptomatic diabetes
  • Advanced vascular complications
  • Manifest renal failure
  • Manifest hepatic disease
  • Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01465152
AGEE-1411
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Mónica Parramón Ponz Novo Nordisk Pharma SA
Novo Nordisk A/S
November 2011

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