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

• Sponsor: Elixir Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00519142
• Collaborator: (none)
• Enrollment: 367
• Locations: 61
• Arms: 3
• Duration (Months): 14
• Patients Per Site: 6
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: placebo for mitiglinide; Drug: mitiglinide; Drug: mitiglinide	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 367 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 metformin + placebo for mitiglinide	Drug: placebo for mitiglinide; three times a day with meals
Experimental: 2 metformin + mitiglinide three times a day with meals	Drug: mitiglinide; three times a day with meals
Experimental: 3 metformin + mitiglinide two times a day with morning and evening meal, placebo for mitiglinide with midday meal	Drug: mitiglinide; two times a day with meals

Outcome Measures

Primary Outcome Measures

1. change from baseline in HbA1c [after 24 weeks of treatment]

Secondary Outcome Measures

1. change from baseline in 2-hour post-prandial glucose [after 24 weeks of treatment]

2. change from baseline in fasting plasma glucose [after 24 weeks of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elixir Study Site	Glendale	Arizona	United States
2	Elixir Study Site	Greenbrae	California	United States
3	Elixir Study Site	La Jolla	California	United States
4	Elixir Study Site	Los Angeles	California	United States
5	Elixir Study Site	Los Gatos	California	United States
6	Elixir Study Site(s)	Oakland Area	California	United States
7	Elixir Study Site	Orange	California	United States
8	Elixir Study Site	West Hills	California	United States	91307
9	Elixir Study Site	Westlake Village	California	United States
10	Elixir Study Site	Pueblo	Colorado	United States
11	Elixir Study Site(s)	Washington	District of Columbia	United States
12	Elixir Study Site	Chiefland	Florida	United States	32626
13	Elixir Study Site	Coral Gables	Florida	United States
14	Elixir Study Site	Kissimmee	Florida	United States
15	Elixir Study Site(s)	Miami	Florida	United States
16	Elixir Study Site	St. Cloud	Florida	United States
17	Elixir Study Site	Winter Park	Florida	United States
18	Elixir Study Site	Atlanta	Georgia	United States	30080
19	Elixir Study Site	Austell	Georgia	United States
20	Elixir Study Site	Perry	Georgia	United States
21	Elixir Study Site(s)	Chicago	Illinois	United States
22	Elixir Study Site	Wichita	Kansas	United States
23	Elixir Study Site	Kansas City	Missouri	United States	64132
24	Elixir Study Site	St Louis	Missouri	United States	63110
25	Elixir Study Site	Las Vegas	Nevada	United States
26	Elixir Study Site	Hamilton	New Jersey	United States
27	Elixir Study Site	Hillsborough	New Jersey	United States
28	Elixir Study Site	Sewell	New Jersey	United States
29	Elixir Study Site(s)	New York	New York	United States
30	Elixir Study Site	Mooresville	North Carolina	United States
31	Elixir Study Site	Morehead City	North Carolina	United States
32	Elixir Study Site	Akron	Ohio	United States
33	Elixir Study Site	Cincinnati	Ohio	United States
34	Elixir Study Site	Gallipolis	Ohio	United States
35	Elixir Study Site	Kettering	Ohio	United States
36	Elixir Study Site	Medford	Oregon	United States
37	Elixir Study Site	Harleysville	Pennsylvania	United States
38	Elixir Study Site	Levittown	Pennsylvania	United States
39	Elixir Study Site	Uniontown	Pennsylvania	United States
40	Elixir Study Site	Columbia	South Carolina	United States
41	Elixir Study Site	Simpsonville	South Carolina	United States
42	Elixir Study Site	Memphis	Tennessee	United States
43	Elixir Study Site	Tullahoma	Tennessee	United States
44	Elixir Study Site(s)	Dallas	Texas	United States
45	Elixir Study Site	El Paso	Texas	United States
46	Elixir Study Site(s)	Fort Worth	Texas	United States
47	Elixir Study Site(s)	Houston	Texas	United States
48	Elixir Study Site	Humble	Texas	United States
49	Elixir Study Site	Midland	Texas	United States
50	Elixir Study Site	N. Richland Hills	Texas	United States
51	Elixir Study Site	New Braunfels	Texas	United States
52	Elixir Study Site	Pearland	Texas	United States
53	Elixir Study Site	Plano	Texas	United States	75074
54	Elixir Study Site(s)	San Antonio	Texas	United States
55	Elixir Study Site	Temple	Texas	United States
56	Elixir Study Site	Norfolk	Virginia	United States
57	Elixir Study Site	Federal Way	Washington	United States
58	Elixir Study Site	Carolina		Puerto Rico	00983
59	Elixir Study Site	Fajardo		Puerto Rico	00738
60	Elixir Study Site(s)	Ponce		Puerto Rico
61	Elixir Study Site(s)	San Juan		Puerto Rico

Sponsors and Collaborators

• Elixir Pharmaceuticals

Investigators

• Study Director: Paul Martha, MD, Elixir Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00519142
• Other Study ID Numbers: EX-1510-CT-003
• First Posted: Aug 22, 2007
• Last Update Posted: Sep 17, 2009
• Last Verified: Sep 1, 2009

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

Study Results

No Results Posted as of Sep 17, 2009