AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00241605

Collaborator

(none)

600

Enrollment

Locations

29.7

Duration (Months)

6.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: rosiglitazone/metformin	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.

Study Start Date :

Jun 25, 2003

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 16, 2005

Outcome Measures

Primary Outcome Measures

Change from baseline in HbA1c at week 48. []

Secondary Outcome Measures

Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria:

Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
Have a known hypersensitivity to thiazolidinediones or biguanides.
Currently using insulin or any oral anti-diabetic agent other than metformin.
History of metabolic acidosis.
History of substance abuse.
Have active cancer other than localized squamous or basal cell carcinoma.
Chronic disease requiring treatment with corticosteroids.
Other criteria will be evaluated at the screening visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Calgary	Alberta	Canada	T1Y 3R6
2	GSK Investigational Site	Calgary	Alberta	Canada	T1Y 6J2
3	GSK Investigational Site	Calgary	Alberta	Canada	T2A 0P9
4	GSK Investigational Site	Calgary	Alberta	Canada	T2L 2V9
5	GSK Investigational Site	Calgary	Alberta	Canada	T3B 0M3
6	GSK Investigational Site	Calgary	Alberta	Canada	T3E 0C5
7	GSK Investigational Site	Calgary	Alberta	Canada	T3E 7C4
8	GSK Investigational Site	Edmonton	Alberta	Canada	T5A 4L8
9	GSK Investigational Site	Edmonton	Alberta	Canada	T6L 6K3
10	GSK Investigational Site	Medicine Hat	Alberta	Canada	T1A 6N9
11	GSK Investigational Site	Aldergrove	British Columbia	Canada	V4W 3L6
12	GSK Investigational Site	Kelowna	British Columbia	Canada	V1Y 3G8
13	GSK Investigational Site	Vancouver	British Columbia	Canada	V5P 3T7
14	GSK Investigational Site	Vancouver	British Columbia	Canada	V5X 3T5
15	GSK Investigational Site	Vancouver	British Columbia	Canada	V7N 4M2
16	GSK Investigational Site	Winnipeg	Manitoba	Canada	R2H 0R8
17	GSK Investigational Site	Winnipeg	Manitoba	Canada	R2J 4A7
18	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3A 1M3
19	GSK Investigational Site	Fredericton	New Brunswick	Canada	E5L 1S1
20	GSK Investigational Site	Houston	New Brunswick	Canada	E6E 1H1
21	GSK Investigational Site	Neguac	New Brunswick	Canada	E9G 4H3
22	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada	A0A 1G0
23	GSK Investigational Site	Carbonear	Newfoundland and Labrador	Canada	A1Y 1C4
24	GSK Investigational Site	Saint John's	Newfoundland and Labrador	Canada	A1A 3R5
25	GSK Investigational Site	Saint John's	Newfoundland and Labrador	Canada	A1B 2X2
26	GSK Investigational Site	Dartmouth	Nova Scotia	Canada	B2W 2S8
27	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3M 3W8
28	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
29	GSK Investigational Site	Upper Tantallon	Nova Scotia	Canada	B3Z 4R4
30	GSK Investigational Site	Ajax	Ontario	Canada	L1S 6N2
31	GSK Investigational Site	Brampton	Ontario	Canada	L6T 3T1
32	GSK Investigational Site	Brampton	Ontario	Canada	L6T 4S5
33	GSK Investigational Site	Burlington	Ontario	Canada	L7M 4Y1
34	GSK Investigational Site	Cambridge	Ontario	Canada	N3C 1Z3
35	GSK Investigational Site	Fort Erie	Ontario	Canada	L2A 1Z3
36	GSK Investigational Site	Hamilton	Ontario	Canada	L8L 5G8
37	GSK Investigational Site	Innisfil	Ontario	Canada	L9S 1L2
38	GSK Investigational Site	Kingston	Ontario	Canada	K7M 1W9
39	GSK Investigational Site	London	Ontario	Canada	N5Y 3J8
40	GSK Investigational Site	London	Ontario	Canada	N6P 1A9
41	GSK Investigational Site	Mississauga	Ontario	Canada	L5B 3A8
42	GSK Investigational Site	Mississauga	Ontario	Canada	L5B 4A9
43	GSK Investigational Site	North York	Ontario	Canada	M3M 3E5
44	GSK Investigational Site	Oakville	Ontario	Canada	L6L 2X4
45	GSK Investigational Site	Oshawa	Ontario	Canada	L1H 1C2
46	GSK Investigational Site	Ottawa	Ontario	Canada	K2G 6E2
47	GSK Investigational Site	Peterborough	Ontario	Canada	K9H 1T6
48	GSK Investigational Site	Rexdale	Ontario	Canada	M9V 4B9
49	GSK Investigational Site	Richmond Hill	Ontario	Canada	L4C 2N9
50	GSK Investigational Site	Scarborough	Ontario	Canada	M1J 2E5
51	GSK Investigational Site	Scarborough	Ontario	Canada	M1R 1R9
52	GSK Investigational Site	Smiths Falls	Ontario	Canada	K7A 2H6
53	GSK Investigational Site	Sutton	Ontario	Canada	L0E 1R0
54	GSK Investigational Site	Toronto	Ontario	Canada	M2M 4J5
55	GSK Investigational Site	Toronto	Ontario	Canada	M5G 1E2
56	GSK Investigational Site	Windsor	Ontario	Canada	B0N 2T0
57	GSK Investigational Site	Woodbridge	Ontario	Canada	L4L 8E2
58	GSK Investigational Site	Woodstock	Ontario	Canada	E7M 1H1
59	GSK Investigational Site	Woodstock	Ontario	Canada	N4S 4H4
60	GSK Investigational Site	Brossard	Quebec	Canada	J4Z 2K9
61	GSK Investigational Site	Charlesbourg	Quebec	Canada	G1G 4A2
62	GSK Investigational Site	Charlesbourg	Quebec	Canada	G1H 6P2
63	GSK Investigational Site	Chateauguay	Quebec	Canada	J6K 3A9
64	GSK Investigational Site	Courcelette	Quebec	Canada	G0A 1R1
65	GSK Investigational Site	Cowansville	Quebec	Canada	J2K 2X9
66	GSK Investigational Site	Hull	Quebec	Canada	J8Y 2E2
67	GSK Investigational Site	Lambton	Quebec	Canada	G0M 1H0
68	GSK Investigational Site	Lle Perrot	Quebec	Canada	H8Y 3J2
69	GSK Investigational Site	Longueuil	Quebec	Canada	J4J 3X5
70	GSK Investigational Site	Longueuil	Quebec	Canada	J4N 1E1
71	GSK Investigational Site	Longueuil	Quebec	Canada	J4N 1L6
72	GSK Investigational Site	Montreal	Quebec	Canada	H1M 2M1
73	GSK Investigational Site	Montreal	Quebec	Canada	H4N 2W2
74	GSK Investigational Site	Pierrefonds	Quebec	Canada	H8Y 3J2
75	GSK Investigational Site	Pointe-Claire	Quebec	Canada	H9R 3J1
76	GSK Investigational Site	Richelieu	Quebec	Canada	J3L 4W6
77	GSK Investigational Site	Saint Charles Borromee	Quebec	Canada	J6E 5A9
78	GSK Investigational Site	Saint Leonard	Quebec	Canada	H1S 3A9
79	GSK Investigational Site	Saint-Jean sur Richelieu	Quebec	Canada	J2X 2B2
80	GSK Investigational Site	Sainte Anne De Bellevue	Quebec	Canada	H9X 1M2
81	GSK Investigational Site	Sainte Catherine	Quebec	Canada	J0L 1E0
82	GSK Investigational Site	Sainte-Foy	Quebec	Canada	G1V 1V6
83	GSK Investigational Site	Sainte-Henri De Levis	Quebec	Canada	G0R 3E0
84	GSK Investigational Site	Salaberry-De-Valleyfield	Quebec	Canada	J6S 4Z5
85	GSK Investigational Site	Thetford Mines	Quebec	Canada	G6G 6H1
86	GSK Investigational Site	Vaudreuil	Quebec	Canada	J7V 8P9
87	GSK Investigational Site	Ville Lasalle	Quebec	Canada	H8N 1X9
88	GSK Investigational Site	Saskatoon	Saskatchewan	Canada	S7K 1N4
89	GSK Investigational Site	Saskatoon	Saskatchewan	Canada	S7L 2W1
90	GSK Investigational Site	Saskatoon	Saskatchewan	Canada	S7M 0Z6
91	GSK Investigational Site	Québec		Canada	G1N 1E1