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NCT00437918 Clinical Trial

The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00437918
Other study ID # PDC-07-01
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2007
Last updated March 21, 2008
Start date January 2007
Est. completion date March 2008

Study information
Verified date March 2008
Source Inje University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Korean

- Type 2 diabetes mellitus

- No prior history of diabetic ketoacidosis

- HbA1c between 7.5-10.0%

Exclusion Criteria:

- Type 1 diabetes mellitus

- Gestational diabetes mellitus

- Secondary diabetes mellitus

- Severe hyperglycemia with symptoms

- Severe chronic diabetic complications (PDR,s-Cr>1.3mg/dL)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• nateglinide

• acarbose

Locations
Country Name City State
Korea, Republic of Endocrinology and Metabolism, Maryknoll General Hospital Busan
Korea, Republic of Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University Busan

Sponsors (2)
Lead Sponsor Collaborator
Inje University Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 7 point SMBG (self monitoring of blood glucose) No
Secondary HOMA-beta for predicting the effectiveness of each agents No
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