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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00437918
Enrollment
85
Registered
2007-02-21
Start date
2007-01-31
Completion date
2008-03-31
Last updated
2008-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus

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.

Interventions

DRUGacarbose

Sponsors

Sanofi
CollaboratorINDUSTRY
Inje University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
7 point SMBG (self monitoring of blood glucose)

Secondary

MeasureTime frame
HOMA-beta for predicting the effectiveness of each agents

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026