Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00616811

Collaborator

(none)

148

Enrollment

Locations

Arms

Duration (Months)

1.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin Drug: Sitagliptin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin	Drug: vildagliptin
Active Comparator: Sitagliptin	Drug: Sitagliptin

Arm

Intervention/Treatment

Experimental: Vildagliptin

Drug: vildagliptin

Active Comparator: Sitagliptin

Drug: Sitagliptin

Outcome Measures

Primary Outcome Measures

Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment [24 weeks]

Secondary Outcome Measures

Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency. [24 weekd]
Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

History T2 DM
Severe Renal Impairment

Exclusion criteria

Glucose ≥ 270 mg/dL (≥15 mmol/L)
Patients undergoing any method of dialysis
Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States
2	Anasazi Internal Medicine	Phoenix	Arizona	United States
3	University of Arkanasas for Medical Sciences	Little Rock	Arkansas	United States
4	Office of William Zigrang	Burlingame	California	United States
5	John Muir Clinical Research	Concord	California	United States
6	Academic Medical Research Institute	Los Angeles	California	United States
7	UCLA Medical Center	Los Angeles	California	United States
8	Northern California Institute for Bone Health	Oakland	California	United States
9	Dr. Wei Feng	Pasadena	California	United States
10	Sierra Clinical Research - Orangevale	Roseville	California	United States
11	Denver Nephrology PC	Denver	Colorado	United States
12	Western Nephrology & Metabolic Bone Disease PC	Lakewood	Colorado	United States
13	Western Nephrology & Metabolic Bone Disease PC	Westminster	Colorado	United States
14	Hartford Hospital	Hartford	Connecticut	United States
15	Nephrology Associates of South Miami	Aventura	Florida	United States
16	University of Florida Shands Hospital	Gainesville	Florida	United States
17	Center for Diabetes & Endocrine Care	Hollywood	Florida	United States
18	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States
19	Osler Medical Clinical Research	Melbourne	Florida	United States
20	Tampa Bay Nephrology Associates	Tampa	Florida	United States
21	Atlanta Diabetes Associates	Atlanta	Georgia	United States
22	Emory Clinic	Atlanta	Georgia	United States
23	University of Hawaii	Honolulu	Hawaii	United States
24	Boise Kidney & Hypertension Institiute	Meridian	Idaho	United States
25	Iowa Diabetes & Endocrinology Research Center PLC	Des Moines	Iowa	United States
26	University of Iowa	Iowa City	Iowa	United States
27	Cray Diabetes Education Center	Kansas City	Kansas	United States
28	Cotton-O'Neil Diabetes & Endocrinology Center	Topeka	Kansas	United States
29	Dolby Research, LLC	Baton Rouge	Louisiana	United States
30	Metabolic Center of Louisiana	Baton Rouge	Louisiana	United States
31	Bruce Samuels LLC	Covington	Louisiana	United States
32	Crescent City Clinical Research Center	Metairie	Louisiana	United States
33	Egan Healthcare	Metairie	Louisiana	United States
34	Arthritis and Diabetes Clinic	Monroe	Louisiana	United States
35	Northwest Louisiana Nephrology Research	Shreveport	Louisiana	United States
36	Joslin Diabetes Center at North Arundel Hospital	Glen Burnie	Maryland	United States
37	Biolab Research, LLC	Rockville	Maryland	United States
38	Genesys Integrated Group Practice, PC	Flint	Michigan	United States
39	Phillips Medical Services, PLLC	Jackson	Mississippi	United States
40	Mississippi Medical Research, LLC	Picayune	Mississippi	United States
41	Diabetes and Endocrinology Specialist, Inc	Chesterfield	Missouri	United States
42	Jefferson City Medical Group	Jefferson City	Missouri	United States
43	Arms, Dodge, Robinson, Wilber & Crouch, Inc.	Kansas City	Missouri	United States
44	Washington U School of Medicine	Saint Louis	Missouri	United States
45	Platte Valley Medical Group	Kearney	Nebraska	United States
46	Creighton Diabetes Center	Omaha	Nebraska	United States
47	Creighton Nephrology	Omaha	Nebraska	United States
48	UMDNJ-Robert Wood Johnson	New Brunswick	New Jersey	United States
49	University of New Mexico Health Science Center	Albuquerque	New Mexico	United States
50	Downstate University of Brooklyn	Brooklyn	New York	United States
51	HRRG	Orchard Park	New York	United States
52	Mayo Clinic Rochester	Rochester	New York	United States
53	SUNY - Upstate Medical University	Syracuse	New York	United States
54	Meritcare Medical Group	Fargo	North Dakota	United States
55	Hightop Medical Research Center	Cincinnati	Ohio	United States
56	University of Cincinnati	Cincinnati	Ohio	United States
57	The Ohio State University Medical Center	Columbus	Ohio	United States
58	Willamette Valley Clinical Studies	Eugene	Oregon	United States
59	Lehigh Valley Hospital-Dept. of Medicine Research	Allentown	Pennsylvania	United States
60	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States
61	Renal Endocrine Associates, P. C.	Pittsburgh	Pennsylvania	United States
62	Aiken Center for Clinical Research	Aiken	South Carolina	United States
63	Medical U of South Carolina	Charleston	South Carolina	United States
64	SC Nephrology and Hyptertension Center, Inc.	Orangeburg	South Carolina	United States
65	Sumter Medical Specialists	Sumter	South Carolina	United States
66	AM Diabetes and Endocrinology Center	Bartlett	Tennessee	United States
67	Medical Nephrology Associates	Dyersburg	Tennessee	United States
68	Dallas Diabetes & Endocrine Center	Dallas	Texas	United States
69	North Texas Endocrine Center	Dallas	Texas	United States
70	Texas Tech University Health Sciences	El Paso	Texas	United States
71	Baylor Clinic (BCM 621)	Houston	Texas	United States
72	Baylor College of Medicine	Houston	Texas	United States
73	Allied Institute of Medicine	San Antonio	Texas	United States
74	Central Utah Clinic	American Fork	Utah	United States
75	Clinical Research and Consulting Center, LLC	Fairfax	Virginia	United States
76	Medical College of Virginia	Richmond	Virginia	United States	23298
77	Medical College of Virginia	Richmond	Virginia	United States
78	Washington State University at Spokane	Spokane	Washington	United States
79	UW Health - West	Madison	Wisconsin	United States