Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00894868

Collaborator

(none)

798

Enrollment

Locations

Arms

Duration (Months)

8.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure Type II Diabetes Mellitus	Drug: vildagliptin Drug: placebo of vildagliptin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

798 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of 52 Weeks Treatment With Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin	Drug: vildagliptin
Placebo Comparator: Placebo	Drug: placebo of vildagliptin

Arm

Intervention/Treatment

Experimental: Vildagliptin

Drug: vildagliptin

Placebo Comparator: Placebo

Drug: placebo of vildagliptin

Outcome Measures

Primary Outcome Measures

To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF). [52 weeks]

Secondary Outcome Measures

To evaluate the overall safety of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I - III) over 52 weeks of treatment with special regard to signs and symptoms of heart failure. [52 weeks]
To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment. [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with T2DM, diagnosed at least 3 months prior to Visit 1
CHF (NYHA Class I, Class II, or Class III) at Visit 1
LVEF < 40%

Exclusion Criteria:

Pregnant or lactating female
FPG ≥ 270 mg/dL (≥15 mmol/L)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Benesov	Czech Republic	Czechia	25601
2	Novartis Investigative Site	Havirov	Czech Republic	Czechia	736 01
3	Novartis Investigative Site	Litomysl	Czech Republic	Czechia	570 14
4	Novartis Investigative Site	Praha 4	Czech Republic	Czechia	140 00
5	Novartis Investigative Site	Praha 2	CZE	Czechia	128 08
6	Novartis Investigative Site	Broumov		Czechia	550 01
7	Novartis Investigative Site	Pardubice		Czechia	53002
8	Novartis Investigative Site	Copenhagen NV		Denmark	DK-2400
9	Novartis Investigative Site	Copenhagen S		Denmark	DK-2300
10	Novartis Investigative Site	Frederiksberg		Denmark	DK-2000
11	Novartis Investigative Site	Hellerup		Denmark	DK-2900
12	Novartis Investigative Site	Roskilde		Denmark	DK-4000
13	Novartis Investigative Site	Slagelse		Denmark	DK-4200
14	Novartis Investigative Site	Pärnu		Estonia	80018
15	Novartis Investigative Site	Tallinn		Estonia	10138
16	Novartis Investigative Site	Tallinn		Estonia	13415
17	Novartis Investigative Site	Tartu		Estonia	50410
18	Novartis Investigative Site	Alsdorf		Germany	52477
19	Novartis Investigative Site	Bad Oeynhausen		Germany	32545
20	Novartis Investigative Site	Dresden		Germany	01307
21	Novartis Investigative Site	Fulda		Germany	36037
22	Novartis Investigative Site	Kamp-Lintfort		Germany	47475
23	Novartis Investigative Site	Saarlouis		Germany	66740
24	Novartis Investigative Site	Senden		Germany	48308
25	Novartis Investigative Site	Alexandroupolis		Greece	GR 68100
26	Novartis Investigative Site	Chios		Greece	82100
27	Novartis Investigative Site	Thessaloniki		Greece	57001
28	Novartis Investigative Site	Guatemala City		Guatemala	01010
29	Novartis Investigative Site	Guatemala City		Guatemala	01011
30	Novartis Investigative Site	Secunderabad	Andhra Pradesh	India	500003
31	Novartis Investigative Site	Visakhapatnam	Andhra Pradesh	India	530002
32	Novartis Investigative Site	Vishakhapatnam	Andhra Pradesh	India	530002
33	Novartis Investigative Site	New Delhi	Delhi	India	110070
34	Novartis Investigative Site	Ahmedabad	Gujarat	India	380014
35	Novartis Investigative Site	Vadodara	Gujrat	India	390015
36	Novartis Investigative Site	Bangalore	Karnataka	India	560078
37	Novartis Investigative Site	Mangalore	Karnataka	India	575002
38	Novartis Investigative Site	Trivandrum	Kerala	India	695011
39	Novartis Investigative Site	Indore	Madhya Pradesh	India	452010
40	Novartis Investigative Site	Nagpur	Maharashtra	India	440012
41	Novartis Investigative Site	Ludhiana	Punjab	India	141001
42	Novartis Investigative Site	Jaipur	Rajasthan	India	302001
43	Novartis Investigative Site	Lucknow	Uttar Pradesh	India	226003
44	Novartis Investigative Site	Bergamo	BG	Italy	24128
45	Novartis Investigative Site	Firenze	FI	Italy	50143
46	Novartis Investigative Site	Milano	MI	Italy	20132
47	Novartis Investigative Site	Passirana Di Rho	MI	Italy	20017
48	Novartis Investigative Site	Pavia	PV	Italy	27100
49	Novartis Investigative Site	Mercato San Severino	SA	Italy	84085
50	Novartis Investigative Site	Siena	SI	Italy	53100
51	Novartis Investigative Site	Novara		Italy	28100
52	Novartis Investigative Site	Daugavpils		Latvia	LV-5401
53	Novartis Investigative Site	Preili		Latvia	LV-5301
54	Novartis Investigative Site	Alytus		Lithuania	LT-62381
55	Novartis Investigative Site	Kaunas		Lithuania	50009
56	Novartis Investigative Site	Vilnius		Lithuania	LT-05261
57	Novartis Investigative Site	Vilnius		Lithuania	LT-08661
58	Novartis Investigative Site	Gdansk		Poland	80-847
59	Novartis Investigative Site	Klodzko		Poland	57-300
60	Novartis Investigative Site	Warsawa		Poland	04-761
61	Novartis Investigative Site	Wroclaw		Poland	50-981
62	Novartis Investigative Site	Bucharest	District 2	Romania	021382
63	Novartis Investigative Site	Craiova	Jud. Dolj	Romania	200147
64	Novartis Investigative Site	Baia-Mare	Maramures	Romania	430071
65	Novartis Investigative Site	Brasov		Romania	500173
66	Novartis Investigative Site	Kaliningrad		Russian Federation	236016
67	Novartis Investigative Site	Kazan		Russian Federation	420012
68	Novartis Investigative Site	Krasnodar		Russian Federation	350072
69	Novartis Investigative Site	Moscow		Russian Federation	113093
70	Novartis Investigative Site	Moscow		Russian Federation	117997
71	Novartis Investigative Site	Moscow		Russian Federation	119048
72	Novartis Investigative Site	Moscow		Russian Federation	121552
73	Novartis Investigative Site	Moscow		Russian Federation	127473
74	Novartis Investigative Site	Moscow		Russian Federation	129110
75	Novartis Investigative Site	N.Novgorod		Russian Federation	603126
76	Novartis Investigative Site	Nizhny Novgorod		Russian Federation	603018
77	Novartis Investigative Site	Penza		Russian Federation	440026
78	Novartis Investigative Site	Petrozavodsk		Russian Federation	185019
79	Novartis Investigative Site	Saint-Petersburg		Russian Federation	193312
80	Novartis Investigative Site	Saint-Petersburg		Russian Federation	197341
81	Novartis Investigative Site	Samara		Russian Federation	443067
82	Novartis Investigative Site	Saratov		Russian Federation	410012
83	Novartis Investigative Site	Saratov		Russian Federation	410031
84	Novartis Investigative Site	St. Petersburg		Russian Federation	198013
85	Novartis Investigative Site	St.- Petersburg		Russian Federation	199034
86	Novartis Investigative Site	Singapore		Singapore	119074
87	Novartis Investigative Site	Singapore		Singapore	168752
88	Novartis Investigative Site	Dunajska Streda	Slovak Republic	Slovakia	929 01
89	Novartis Investigative Site	Nitra	Slovak Republic	Slovakia	949 01
90	Novartis Investigative Site	Banska Bystrica		Slovakia	974 01
91	Novartis Investigative Site	Komarno		Slovakia	945 01
92	Novartis Investigative Site	Kosice		Slovakia	040 01
93	Novartis Investigative Site	Lucenec		Slovakia	98439
94	Novartis Investigative Site	Modava Nad Bodvou		Slovakia	045 01