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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00568984
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: metformin Drug: glicazide Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
Actual Study Start Date : November 21, 2002
Primary Completion Date : November 10, 2003
Study Completion Date : November 10, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 16 weeks of treatment ]

Secondary Outcome Measures :
  1. Glucose profiles
  2. Quality of life assessment
  3. Treatment satisfaction
  4. Hypoglycaemic events
  5. Adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568984


Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100034
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100044
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100730
China, Tianjin
Novo Nordisk Investigational Site
Tianjin, Tianjin, China, 300052
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Ipoh, Malaysia, 30450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Novo Nordisk Investigational Site
Cebu City, Philippines, 6000
Novo Nordisk Investigational Site
Manila, Philippines, 1003
Novo Nordisk Investigational Site
Marikina City, Philippines, 1800
Novo Nordisk Investigational Site
Pampanga, Philippines, 2000
Novo Nordisk Investigational Site
Quezon City, Philippines, 1100
Novo Nordisk Investigational Site
Quezon, Philippines, 4301
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10300
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00568984     History of Changes
Other Study ID Numbers: AGEE-3017
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

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