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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00568984
First received: December 4, 2007
Last updated: June 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: repaglinide
Drug: metformin
Drug: glicazide
 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: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • glucose profiles [ Designated as safety issue: No ]
  • Quality of life assessment [ Designated as safety issue: No ]
  • Treatment satisfaction [ Designated as safety issue: No ]
  • Hypoglycaemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: November 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568984

Locations
China, Beijing
Beijing, Beijing, China, 100034
Malaysia
Cheras, Malaysia, 56000
Philippines
Manila, Philippines, 1003
Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jing Ping Yeo Novo Nordisk Asia Pacific Pte.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00568984     History of Changes
Other Study ID Numbers: AGEE-3017
Study First Received: December 4, 2007
Last Updated: June 5, 2012
Health Authority: China: Food and Drug Administration
Thailand: Ministry of Public Health
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs

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 May 19, 2013