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

• Sponsor: Inje University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00437918
• Collaborator: Sanofi (Industry)
• Enrollment: 85
• Locations: 2
• Duration (Months): 14
• Patients Per Site: 42.5
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Type 2 Diabetes Mellitus	Drug: nateglinide; Drug: acarbose	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Outcome Measures

Primary Outcome Measures

1. 7 point SMBG (self monitoring of blood glucose) []

Secondary Outcome Measures

1. HOMA-beta for predicting the effectiveness of each agents []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University	Busan		Korea, Republic of	614-735
2	Endocrinology and Metabolism, Maryknoll General Hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Inje University
• Sanofi

Investigators

• Principal Investigator: Jeonghyun Park, MD PhD, Director, Paik Diabetes Center, Pusan Paik Hospital, College of Medicine, Inje University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00437918
• Other Study ID Numbers: PDC-07-01
• First Posted: Feb 21, 2007
• Last Update Posted: Mar 24, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Acarbose; Nateglinide

Study Results

No Results Posted as of Mar 24, 2008