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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01465152
First received: October 31, 2011
Last updated: February 17, 2017
Last verified: February 2017

October 31, 2011
February 17, 2017
March 6, 2002
October 21, 2004   (Final data collection date for primary outcome measure)
Change of % HbA1c (glycosylated haemoglobin) in blood
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
  • Incidence of clinical and/or biochemistry hypoglycaemia episodes
  • Incidence of adverse events
  • Presence of laboratory abnormalities in routine blood analyses
  • Change of the blood pressure and/or heart rate
  • Treatment compliance
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
Intervention Model: Parallel Assignment
Masking: No masking
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 21, 2004
October 21, 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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01465152
AGEE-1411
No
Not Provided
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