Double-Blind Comparison Between Mitiglinide and Nateglinide in Type 2 Diabetic Patients

Diabetes Clinical Trial

Official title:

Multicentre, Double-Dummy, Randomized, Double-Blind Comparison Between Mitiglinide and Nateglinide in the Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461617
• Other study ID #: KAD1301
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2007
• Last updated: October 20, 2008
• Start date: August 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2007
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy

Exclusion Criteria:

• Type 1 diabetes patients

• Patients who require treatment with insulin

• Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)

• Patients with severe ketosis, diabetic coma or precoma

• Patients complicated with severe hepatic diseases

• Patients complicated with severe renal diseases

• Patients complicated with severe hypertension

• Patients complicated with severe cardiac disease

• Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Mitiglinide
10mg tablet, 10mg TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C (HbA1C)		-2, 0, 4, 8, 10, 12, 16, 20 week	No
Secondary	Fasting plasma glucose level (FPG)		0, 4, 8, 12, 16, 20 week	No
Secondary	Two-hour postprandial glucose level (PPG2)		0, 12, 20 week	No
Secondary	One-hour postprandial glucose level (PPG1)		0, 12, 20 week	No