The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients
Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy
1 other identifier
interventional
85
1 country
2
Brief Summary
In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus
Started Jan 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedMarch 24, 2008
March 1, 2008
1.2 years
February 20, 2007
March 21, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
7 point SMBG (self monitoring of blood glucose)
Secondary Outcomes (1)
HOMA-beta for predicting the effectiveness of each agents
Interventions
Eligibility Criteria
You may qualify if:
- Korean
- Type 2 diabetes mellitus
- No prior history of diabetic ketoacidosis
- HbA1c between 7.5-10.0%
You may not qualify if:
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- Secondary diabetes mellitus
- Severe hyperglycemia with symptoms
- Severe chronic diabetic complications (PDR,s-Cr\>1.3mg/dL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
- Sanoficollaborator
Study Sites (2)
Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
Busan, 614-735, South Korea
Endocrinology and Metabolism, Maryknoll General Hospital
Busan, South Korea
Related Publications (1)
Kim MK, Suk JH, Kwon MJ, Chung HS, Yoon CS, Jun HJ, Ko JH, Kim TK, Lee SH, Oh MK, Rhee BD, Park JH. Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jun;92(3):322-8. doi: 10.1016/j.diabres.2011.01.022. Epub 2011 Mar 3.
PMID: 21376417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeonghyun Park, MD PhD
Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 21, 2007
Study Start
January 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
March 24, 2008
Record last verified: 2008-03