Combination of Glinides With Premixed Insulin | NCT00369148

Studies
Combination of Glinides With Premixed Insulin

NCT00369148

Sponsor

Keio University

Status

Completed

Last Update Posted

Aug 26, 2009Estimated

Enrollment

Phase

Phase 4

Conditions

Type 2 Diabets Mellitus

Interventions

nateglinide(drug) mitiglinide(drug)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Aug 28, 2006

First Submission Date that Met QC Criteria

Aug 28, 2006

First Posted Date

Aug 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2009

Last Update Posted Date

Aug 26, 2009Estimated

Description Module

Brief Summary

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Detailed Description

Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
nateglinide(drug) mitiglinide(drug)	Drug

Measure	Description	Time Frame
glycohemoglobin

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of type 2 diabetes
Who undergoes twice daily injection of premixed insulin
Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion Criteria:

Whose change of HbA1c is more than 1.0% during 12 weeks observational period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akira Shimada, MD, PhD	Keio University	Study Chair
Yoshihito Atsumi, MD	Saiseikai Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nippon Kokan Hospital		Kawasaki	Kanagawa	210-0852	Japan
Hamamatsu Red Cross Hospital

Measure	Description	Time Frame
anhydroglucitol
lipid profile
body weight