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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
metformin
repaglinide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Met

Rep

Met+Rep

Arm Description

Outcomes

Primary Outcome Measures

Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2011
Last Updated
February 17, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01465152
Brief Title
Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 6, 2002 (Actual)
Primary Completion Date
October 21, 2004 (Actual)
Study Completion Date
October 21, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Met
Arm Type
Experimental
Arm Title
Rep
Arm Type
Active Comparator
Arm Title
Met+Rep
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Adminstered orally during the three main meals for 24 weeks
Intervention Type
Drug
Intervention Name(s)
repaglinide
Intervention Description
Administered orally before the three main meals for 24 weeks
Primary Outcome Measure Information:
Title
Change of % HbA1c (glycosylated haemoglobin) in blood
Secondary Outcome Measure Information:
Title
Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
Title
Incidence of clinical and/or biochemistry hypoglycaemia episodes
Title
Incidence of adverse events
Title
Presence of laboratory abnormalities in routine blood analyses
Title
Change of the blood pressure and/or heart rate
Title
Treatment compliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08020
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Benamargosa
ZIP/Postal Code
29718
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Burlada
ZIP/Postal Code
31600
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Camas
ZIP/Postal Code
41900
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Gijón
ZIP/Postal Code
33212
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28021
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28030
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Portugalete
ZIP/Postal Code
48920
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
San Adria del Besos
ZIP/Postal Code
08930
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santander
ZIP/Postal Code
39009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santander
ZIP/Postal Code
39011
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Tegueste
ZIP/Postal Code
38280
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46021
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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