Clinical trial NCT00519142: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Elixir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change from baseline in HbA1c
timeFrame: after 24 weeks of treatment
Secondary outcomes:
measure: change from baseline in 2-hour post-prandial glucose
timeFrame: after 24 weeks of treatment
measure: change from baseline in fasting plasma glucose
timeFrame: after 24 weeks of treatment
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Elixir Study Site
state: Arizona
city: Greenbrae
country: United States
facility: Elixir Study Site
state: California
city: La Jolla
country: United States
facility: Elixir Study Site
state: California
city: Los Angeles
country: United States
facility: Elixir Study Site
state: California
city: Los Gatos
country: United States
facility: Elixir Study Site
state: California
city: Oakland Area
country: United States
facility: Elixir Study Site(s)
state: California
city: Orange
country: United States
facility: Elixir Study Site
state: California
city: West Hills
country: United States
facility: Elixir Study Site
state: California
city: Westlake Village
country: United States
facility: Elixir Study Site
state: California
city: Pueblo
country: United States
facility: Elixir Study Site
state: Colorado
city: Washington
country: United States
facility: Elixir Study Site(s)
state: District of Columbia
city: Chiefland
country: United States
facility: Elixir Study Site
state: Florida
city: Coral Gables
country: United States
facility: Elixir Study Site
state: Florida
city: Kissimmee
country: United States
facility: Elixir Study Site
state: Florida
city: Miami
country: United States
facility: Elixir Study Site(s)
state: Florida
city: St. Cloud
country: United States
facility: Elixir Study Site
state: Florida
city: Winter Park
country: United States
facility: Elixir Study Site
state: Florida
city: Atlanta
country: United States
facility: Elixir Study Site
state: Georgia
city: Austell
country: United States
facility: Elixir Study Site
state: Georgia
city: Perry
country: United States
facility: Elixir Study Site
state: Georgia
city: Chicago
country: United States
facility: Elixir Study Site(s)
state: Illinois
city: Wichita
country: United States
facility: Elixir Study Site
state: Kansas
city: Kansas City
country: United States
facility: Elixir Study Site
state: Missouri
city: St Louis
country: United States
facility: Elixir Study Site
state: Missouri
city: Las Vegas
country: United States
facility: Elixir Study Site
state: Nevada
city: Hamilton
country: United States
facility: Elixir Study Site
state: New Jersey
city: Hillsborough
country: United States
facility: Elixir Study Site
state: New Jersey
city: Sewell
country: United States
facility: Elixir Study Site
state: New Jersey
city: New York
country: United States
facility: Elixir Study Site(s)
state: New York
city: Mooresville
country: United States
facility: Elixir Study Site
state: North Carolina
city: Morehead City
country: United States
facility: Elixir Study Site
state: North Carolina
city: Akron
country: United States
facility: Elixir Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Elixir Study Site
state: Ohio
city: Gallipolis
country: United States
facility: Elixir Study Site
state: Ohio
city: Kettering
country: United States
facility: Elixir Study Site
state: Ohio
city: Medford
country: United States
facility: Elixir Study Site
state: Oregon
city: Harleysville
country: United States
facility: Elixir Study Site
state: Pennsylvania
city: Levittown
country: United States
facility: Elixir Study Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Elixir Study Site
state: Pennsylvania
city: Columbia
country: United States
facility: Elixir Study Site
state: South Carolina
city: Simpsonville
country: United States
facility: Elixir Study Site
state: South Carolina
city: Memphis
country: United States
facility: Elixir Study Site
state: Tennessee
city: Tullahoma
country: United States
facility: Elixir Study Site
state: Tennessee
city: Dallas
country: United States
facility: Elixir Study Site(s)
state: Texas
city: El Paso
country: United States
facility: Elixir Study Site
state: Texas
city: Fort Worth
country: United States
facility: Elixir Study Site(s)
state: Texas
city: Houston
country: United States
facility: Elixir Study Site(s)
state: Texas
city: Humble
country: United States
facility: Elixir Study Site
state: Texas
city: Midland
country: United States
facility: Elixir Study Site
state: Texas
city: N. Richland Hills
country: United States
facility: Elixir Study Site
state: Texas
city: New Braunfels
country: United States
facility: Elixir Study Site
state: Texas
city: Pearland
country: United States
facility: Elixir Study Site
state: Texas
city: Plano
country: United States
facility: Elixir Study Site
state: Texas
city: San Antonio
country: United States
facility: Elixir Study Site(s)
state: Texas
city: Temple
country: United States
facility: Elixir Study Site
state: Texas
city: Norfolk
country: United States
facility: Elixir Study Site
state: Virginia
city: Federal Way
country: United States
facility: Elixir Study Site
state: Washington
city: Carolina
country: Puerto Rico
facility: Elixir Study Site
city: Fajardo
country: Puerto Rico
facility: Elixir Study Site
city: Ponce
country: Puerto Rico
facility: Elixir Study Site(s)
city: San Juan
country: Puerto Rico
facility: Elixir Study Site(s)
Study officials:
affiliation: Elixir Pharmaceuticals
name: Paul Martha, MD
role: STUDY_DIRECTOR
References: