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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 A/S
ClinicalTrials.gov Identifier:
NCT00568984
First received: December 4, 2007
Last updated: June 5, 2012
Last verified: January 2012
  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:


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

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
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: 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 A/S
Investigators
Study Director: Jing Ping Yeo Novo Nordisk Asia Pacific Pte.
  More Information

Additional Information:
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Repaglinide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014