LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts

NCT ID: NCT01544309

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1049 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31

Brief Summary

The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.

Conditions

Hypercholesterolemia With Concomitant Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atorvastatin administration group

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.

(When not reach the LDL-C level of target in the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.)

Rosuvastatin administration group

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.

(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)

Interventions

Atorvastatin

Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.

(When not reach the LDL-C level of target in the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.)

Intervention Type: DRUG

Rosuvastatin

Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.

(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)

Intervention Type: DRUG

Other Intervention Names

Lipitor; Crestor

Eligibility Criteria

Inclusion Criteria

1. Hypercholesterolemia patients

• Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"

2. Type 2 diabetes patients

• Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication
• Patients who received constant therapy for three months before registration and have no plan for therapy change
• Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration
• Patients receiving or not receiving medication at present

3. Patients giving voluntary written consent to participate in the study

4. Male or female patients at 20 years or older

Exclusion Criteria

1. Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration

2. Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)

3. Patients with type 1 diabetes

4. Patients judged to have familial hypercholesterolemia

5. Patients with a serum triglyceride level of ≥ 400 mg/dL

6. Patients who had the onset of cardiovascular or cerebrovascular disease within three months

7. Patients with serious heart failure (NYHA classification III - IV)

8. Patients with a history of hypersensitivity to statins

9. Patients with a history of drug-induced myopathy

10. Patients with severe complication of diabetes

11. Patients receiving insulin

12. Patients with serious liver or kidney disease

13. Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan

14. Patients who are or may be pregnant

15. Patients judged by the investigators to be ineligible for participation in the study for any other reason

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Listen Trial Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hisao Ogawa, Ph.D

Role: STUDY_CHAIR

Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University

Locations

Hiramitsu Heart Clinic

Nagoya, Aichi Pref., Japan

Honjo Daiichi Hospital

Yurihonjō, Akita Pref., Japan

Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin

Matsudo, Chiba Pref., Japan

Matsuno Medical Clinic

Iyo Gun, Ehime Pref., Japan

Ishite Matsumoto Naika Junkanki Clinic

Matsuyama, Ehime Pref., Japan

Ehime Medical CO OP Izumigawa Clinic

Niihama, Ehime Pref., Japan

Fukui Chuoh Clinic

Fukui, Fukui Pref., Japan

Fukuoka City Medical Association Hospital

Fukuoka, Fukuoka Pref., Japan

Matsumoto Clinic

Fukuoka, Fukuoka Pref., Japan

Saku Hospital

Fukuoka, Fukuoka Pref., Japan

Soejima Medical Clinic

Fukuoka, Fukuoka Pref., Japan

Takei's Clinic Internal Medicine

Fukuoka, Fukuoka Pref., Japan

Nakamura Cardiovascular Clinic

Itoshima, Fukuoka Pref., Japan

Morizono Naika

Kitakyushu, Fukuoka Pref., Japan

Seino Internal Medicine Clinic

Kōriyama, Fukushima Pref., Japan

Yasue Naika

Gifu, Gifu City, Japan

Kawade Iin

Gifu, Gifu Pref., Japan

Hashimoto Naika Clinic

Gifu, Gifu Pref., Japan

Iinuma Iin

Gifu, Gifu Pref., Japan

Ishimura Clinic

Gifu, Gifu Pref., Japan

Kawai Clinic

Gifu, Gifu Pref., Japan

Niimi Clinic

Gifu, Gifu Pref., Japan

Takai Clinic

Gifu, Gifu Pref., Japan

Kobayashi Internal Medicine

Kakamigahara, Gifu Pref., Japan

Horibe Clinic

Motosu, Gifu Pref., Japan

Kondo Cardiovascular Clinic

Ōgaki, Gifu Pref., Japan

Yoshida Naika

Ōgaki, Gifu Pref., Japan

Kogure Clinic

Maebashi, Gunma Pref., Japan

Nakano Clinic

Shibukawa, Gunma Pref., Japan

Yoshii Central Clinic

Takasaki, Gunma Pref., Japan

Shigenobu Clinic

Miyoshi, Hiroshima Pref., Japan

Takahashi Kiyohito Clinic

Hakodate, Hokkaido Pref., Japan

Hokuto Internal Medicine Clinic

Sapporo, Hokkaido Pref., Japan

Katsuya Clinic

Amagasaki, Hyogo Pref., Japan

Nakatani Hospital

Himeji, Hyogo Pref., Japan

Kosumo Clinic

Kako Gun, Hyogo Pref., Japan

Harima Clinic

Kakogawa, Hyogo Pref., Japan

Kusunose Clinic

Kobe, Hyogo Pref., Japan

Yanagi Medical Clinic

Hakusan, Ishikawa Pref., Japan

Okyozuka Clinic

Ishikawa Gun, Ishikawa Pref., Japan

Doniwa Clinic

Kanazawa, Ishikawa Pref., Japan

Wakasa Medical Clinic

Kanazawa, Ishikawa Pref., Japan

Association Medical Corporation Neurology Internal Medicine Kanamori Clinic

Iwate Gun, Iwate Pref., Japan

Medical Corporation Kuon-kai Kamata Medical Clinic

Morioka, Iwate Pref., Japan

Kagawa Clinic

Marugame, Kagawa Pref., Japan

Hasegawa Outpatients Clinic for Cardiovascular Disease

Takamatsu, Kagawa Pref., Japan

Tempozan Naika Clinic

Kagoshima, Kagoshima Pref., Japan

Kashiwagi Clinic

Ayase, Kanagawa Pref., Japan

Hayashi Diabetes Clinic

Chigasaki, Kanagawa Pref., Japan

Takada Internal Medicine Clinic

Hiratsuka, Kanagawa Pref., Japan

Iroden Clinic

Kamakura, Kanagawa Pref., Japan

Nagasu Clinic

Kamakura, Kanagawa Pref., Japan

Kobayashi Hospital

Odawara, Kanagawa Pref., Japan

Hakuai Iin

Sagamihara, Kanagawa Pref., Japan

Yamamoto Clinic

Sagamihara, Kanagawa Pref., Japan

Arima Clinic

Yokohama, Kanagawa Pref., Japan

Kikuchi Clinic

Yokohama, Kanagawa Pref., Japan

Miho cho Cardiovascular Medical Clinic

Yokohama, Kanagawa Pref., Japan

Minamisawa Clinic

Yokohama, Kanagawa Pref., Japan

Shimokurata Heart Clinic

Yokohama, Kanagawa Pref., Japan

Yokohama Sotetsu Bldg. Clinic of Internal Medicine

Yokohama, Kanagawa Pref., Japan

Jinnouchi Clinic Diabetes Care Center

Kumamoto, Kumamoto Pref., Japan

Maki Cardiovascular Clinic

Kumamoto, Kumamoto Pref., Japan

Munakata Clinic

Kumamoto, Kumamoto Pref., Japan

Terao Hospital

Kumamoto, Kumamoto Pref., Japan

Higashi Diabetes and Cardiovascular Clinic

Tamana, Kumamoto Pref., Japan

Matsuo Clinic

Tamana, Kumamoto Pref., Japan

Miyagi Clinic Cardiovascular Medicine

Yatsushiro, Kumamoto Pref., Japan

Asamoto Internal Medical Clinic

Kyoto, Kyoto Pref., Japan

Ijinkai Takeda General Hospital

Kyoto, Kyoto Pref., Japan

Koseikai Clinic

Kyoto, Kyoto Pref., Japan

Sakabe International Clinic

Kyoto, Kyoto Pref., Japan

Takenaka Clinic

Kyoto, Kyoto Pref., Japan

Tegoshi Clinic

Kyoto, Kyoto Pref., Japan

Sawai Naika Iin

Kyōtanabe, Kyoto Pref., Japan

Iwasaki Hospital

Tsu, Mie Pref., Japan

Ishikawa Clinic

Miyazaki, Miyazaki Pref., Japan

Yokota Naika

Miyazaki, Miyazaki Pref., Japan

Etou Clinic

Nichinan, Miyazaki Pref., Japan

Kawano Clinic

Nichinan, Miyazaki Pref., Japan

Yamaguchi Clinic

Nichinan, Miyazaki Pref., Japan

Hasegawa Clinic

Nakano City, Nagano Pref., Japan

Nara Prefectural Gojo Hospital

Gojō, Nara Pref., Japan

Fujii Internal Medicine Clinic

Kashihara, Nara Pref., Japan

Matsuoka Clinic

Kita Katsuragi Gun, Nara Pref., Japan

Ote Clinic of Internal

Sakurai, Nara Pref., Japan

Uchiyama Clinic

Jōetsu, Niigata Pref., Japan

Inoue Clinic

Niigata, Niigata Pref., Japan

Maeda Medical Clinic

Niigata, Niigata Pref., Japan

Nishimura Clinic

Fujiidera, Osaka Pref., Japan

Shoseikai Matsuda Iin

Fujiidera, Osaka Pref., Japan

Ikeda Clinic

Higashiosaka, Osaka Pref., Japan

Kanazawa Clinic

Izumi, Osaka Pref., Japan

Fukuda Clinic

Osaka, Osaka Pref., Japan

Jikuhara Clinic

Osaka, Osaka Pref., Japan

Kawagishi-naika Clinic

Osaka, Osaka Pref., Japan

Kinugawa Cardiology Clinic

Osaka, Osaka Pref., Japan

Kubota Clinic

Osaka, Osaka Pref., Japan

Masaki Clinic

Osaka, Osaka Pref., Japan

Nanko Clinic

Osaka, Osaka Pref., Japan

Osaka Ekisaikai Hospital

Osaka, Osaka Pref., Japan

Tamatani Clinic

Osaka, Osaka Pref., Japan

Hayashi Clinic

Sakai, Osaka Pref., Japan

Nakao Medical Clinic

Sakai, Osaka Pref., Japan

Saga Memorial Clinic

Saga, Saga Pref., Japan

Enomoto Clinic

Ageo, Saitama Pref., Japan

Asano Internal Medicine Clinic

Kawagoe, Saitama Pref., Japan

Iryohojin Hogi Sinryojyo

Kawaguchi, Saitama Pref., Japan

Tokutake Iin

Kawaguchi, Saitama Pref., Japan

Medical Corporation Shibuya Clinic

Kumagaya, Saitama Pref., Japan

Tanaka Medical Clinic

Saitama, Saitama Pref., Japan

Yoshimura Eye&Internal Medical Clinic

Mishima, Shizuoka Pref., Japan

Shizuoka Municipal Hospital

Shizuoka, Shizuoka Pref., Japan

Takada Clinic

Tochigi, Tochigi Pref., Japan

Murakami Clinic

Anan, Tokushima Pref., Japan

Ota Clinic

Awa, Tokushima Pref., Japan

Arizumi Clinic

Itano Gun, Tokushima Pref., Japan

Yuki National Health Insurance Hospital of Minami Town

Kaifu Gun, Tokushima Pref., Japan

Sekishinkan Hospital

Komatsushima, Tokushima Pref., Japan

Iryohojin Tokujikai Tanaka Iin

Myozai Gun, Tokushima Pref., Japan

Kensei Uchimachi Clinic

Tokushima, Tokushima Pref., Japan

Yata Clinic

Yoshinogawa, Tokushima Pref., Japan

Tokyo Center Clinic

Chuo Ku, Tokyo, Japan

Okudo Poly Clinic

Katsushika-ku, Tokyo, Japan

Nakano Sunbright Clinic

Nakano Ku, Tokyo, Japan

Sugawara Clinic

Nerima Ku, Tokyo, Japan

Tsurumachi Clinic

Setagaya Ku, Tokyo, Japan

Oda Clinic

Shinjuku Ku, Tokyo, Japan

Ishii Clinic

Tachikawa, Tokyo, Japan

Ayame Medical Clinic

Shimonoseki, Yamaguchi Pref., Japan

Matsuda Medical Clinic

Shimonoseki, Yamaguchi Pref., Japan

Mizumachi Medical Clinic

Shimonoseki, Yamaguchi Pref., Japan

Kuroda Iin

Ōtsuki, Yamanashi Pref., Japan

Countries

Japan

References

Ogawa H, Matsui K, Saito Y, Sugiyama S, Jinnouchi H, Sugawara M, Masuda I, Mori H, Waki M, Yoshiyama M, Watada H. Differences between rosuvastatin and atorvastatin in lipid-lowering action and effect on glucose metabolism in Japanese hypercholesterolemic patients with concurrent diabetes. Lipid-lowering with highly potent statins in hyperlipidemia with type 2 diabetes patients (LISTEN) study -. Circ J. 2014;78(10):2512-5. doi: 10.1253/circj.cj-14-0810. Epub 2014 Sep 2.

Reference Type: DERIVED

PMID: 25186922 (View on PubMed)

Other Identifiers

0059

Identifier Type: -

Identifier Source: org_study_id