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Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo for mitiglinide
mitiglinide
mitiglinide
Sponsored by
Elixir Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes diagnosed for at least 6 months
  • stable metformin usage for at least 4 months
  • HbA1c 7.5% - 10.5% inclusive
  • no severe diabetic complications

Exclusion Criteria:

  • chronic insulin use
  • use of oral diabetic agent within 12 weeks
  • acute or chronic conditions, excluding diabetes, that could compromise end point evaluation

Sites / Locations

  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site
  • Elixir Study Site(s)
  • Elixir Study Site(s)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

metformin + placebo for mitiglinide

metformin + mitiglinide three times a day with meals

metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal

Outcomes

Primary Outcome Measures

change from baseline in HbA1c

Secondary Outcome Measures

change from baseline in 2-hour post-prandial glucose
change from baseline in fasting plasma glucose

Full Information

First Posted
August 20, 2007
Last Updated
September 16, 2009
Sponsor
Elixir Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00519142
Brief Title
Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
Official Title
A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Elixir Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients with T2DM who are less than adequately controlled on metformin alone. Patients who are receiving metformin alone for T2DM will be randomized equally into one of three treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
metformin + placebo for mitiglinide
Arm Title
2
Arm Type
Experimental
Arm Description
metformin + mitiglinide three times a day with meals
Arm Title
3
Arm Type
Experimental
Arm Description
metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal
Intervention Type
Drug
Intervention Name(s)
placebo for mitiglinide
Intervention Description
three times a day with meals
Intervention Type
Drug
Intervention Name(s)
mitiglinide
Intervention Description
three times a day with meals
Intervention Type
Drug
Intervention Name(s)
mitiglinide
Intervention Description
two times a day with meals
Primary Outcome Measure Information:
Title
change from baseline in HbA1c
Time Frame
after 24 weeks of treatment
Secondary Outcome Measure Information:
Title
change from baseline in 2-hour post-prandial glucose
Time Frame
after 24 weeks of treatment
Title
change from baseline in fasting plasma glucose
Time Frame
after 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes diagnosed for at least 6 months stable metformin usage for at least 4 months HbA1c 7.5% - 10.5% inclusive no severe diabetic complications Exclusion Criteria: chronic insulin use use of oral diabetic agent within 12 weeks acute or chronic conditions, excluding diabetes, that could compromise end point evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Martha, MD
Organizational Affiliation
Elixir Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Elixir Study Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Elixir Study Site
City
Greenbrae
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
Los Gatos
State/Province
California
Country
United States
Facility Name
Elixir Study Site(s)
City
Oakland Area
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
Orange
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Elixir Study Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
Elixir Study Site
City
Pueblo
State/Province
Colorado
Country
United States
Facility Name
Elixir Study Site(s)
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Elixir Study Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Elixir Study Site
City
Coral Gables
State/Province
Florida
Country
United States
Facility Name
Elixir Study Site
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
Elixir Study Site(s)
City
Miami
State/Province
Florida
Country
United States
Facility Name
Elixir Study Site
City
St. Cloud
State/Province
Florida
Country
United States
Facility Name
Elixir Study Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Elixir Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Elixir Study Site
City
Austell
State/Province
Georgia
Country
United States
Facility Name
Elixir Study Site
City
Perry
State/Province
Georgia
Country
United States
Facility Name
Elixir Study Site(s)
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Elixir Study Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Elixir Study Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Elixir Study Site
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Elixir Study Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Elixir Study Site
City
Hamilton
State/Province
New Jersey
Country
United States
Facility Name
Elixir Study Site
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Elixir Study Site
City
Sewell
State/Province
New Jersey
Country
United States
Facility Name
Elixir Study Site(s)
City
New York
State/Province
New York
Country
United States
Facility Name
Elixir Study Site
City
Mooresville
State/Province
North Carolina
Country
United States
Facility Name
Elixir Study Site
City
Morehead City
State/Province
North Carolina
Country
United States
Facility Name
Elixir Study Site
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Elixir Study Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Elixir Study Site
City
Gallipolis
State/Province
Ohio
Country
United States
Facility Name
Elixir Study Site
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
Elixir Study Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Elixir Study Site
City
Harleysville
State/Province
Pennsylvania
Country
United States
Facility Name
Elixir Study Site
City
Levittown
State/Province
Pennsylvania
Country
United States
Facility Name
Elixir Study Site
City
Uniontown
State/Province
Pennsylvania
Country
United States
Facility Name
Elixir Study Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Elixir Study Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Elixir Study Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Elixir Study Site
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
Elixir Study Site(s)
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site(s)
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site(s)
City
Houston
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Humble
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Midland
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
N. Richland Hills
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Pearland
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75074
Country
United States
Facility Name
Elixir Study Site(s)
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Temple
State/Province
Texas
Country
United States
Facility Name
Elixir Study Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Elixir Study Site
City
Federal Way
State/Province
Washington
Country
United States
Facility Name
Elixir Study Site
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
Elixir Study Site
City
Fajardo
ZIP/Postal Code
00738
Country
Puerto Rico
Facility Name
Elixir Study Site(s)
City
Ponce
Country
Puerto Rico
Facility Name
Elixir Study Site(s)
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus

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