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
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: metformin
Drug: repaglinide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change of % HbA1c (glycosylated haemoglobin) in blood [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 182
Study Start Date: March 2002
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Met Drug: metformin
Adminstered orally during the three main meals for 24 weeks
Active Comparator: Rep Drug: repaglinide
Administered orally before the three main meals for 24 weeks
Active Comparator: Met+Rep Drug: metformin
Adminstered orally during the three main meals for 24 weeks
Drug: repaglinide
Administered orally before the three main meals for 24 weeks

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465152

Locations
Spain
Zaragoza, Spain, 50007
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mónica Parramón Ponz Novo Nordisk Pharma SA
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01465152     History of Changes
Other Study ID Numbers: AGEE-1411
Study First Received: October 31, 2011
Last Updated: November 3, 2011
Health Authority: Spain: Spanish agency of medicines and health care products

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014