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

Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus

Sponsors

Lead Sponsor: Listen Trial Group

Source Listen Trial Group
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.

Overall Status Completed
Start Date 2012-03-01
Primary Completion Date 2014-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level Baseline, and 12 months after administration
Change in HbA1c Level Baseline, 12 months after administration
Secondary Outcome
Measure Time Frame
Occurrence of Deterioration of Diabetic Treatment Status Baseline, 12 months after administration
Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status Baseline, 3, 6, 12 months after administration
Percent Change in 1,5-AG Level Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Change in HbA1c Level Baseline, 3, 6 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)
Percent Change in Blood Glucose Level (Fasting) Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Change in Blood Glucose Level (Fasting) Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Percent Change in Insulin Level Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)
Change From Baseline in Insulin Level Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)
Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) From the start of the treatment to the end of study treatment
Frequency of Serious Adverse Events (SAE) Up to 12 months
Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
Percent Change in Non-HDL-C Level Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment
Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 3 months after administration, the end of starting dose and the end of study treatment
Change From Baseline in 1,5-AG Level Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Enrollment 1049
Condition
Intervention

Intervention Type: Drug

Intervention Name: Atorvastatin

Description: 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.)

Arm Group Label: Atorvastatin administration group

Other Name: Lipitor

Intervention Type: Drug

Intervention Name: Rosuvastatin

Description: 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.)

Arm Group Label: Rosuvastatin administration group

Other Name: 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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hisao Ogawa, Ph.D Study Chair Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
Location
Facility:
Hiramitsu Heart Clinic | Nagoya city, Aichi pref., Japan
Honjo Daiichi Hospital | Yurihonjo city, Akita pref., Japan
Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin | Matsudo city, Chiba pref., Japan
Matsuno Medical Clinic | Iyo gun, Ehime pref., Japan
Ishite Matsumoto Naika Junkanki Clinic | Matsuyama city, Ehime pref., Japan
Ehime Medical CO OP Izumigawa Clinic | Niihama city, Ehime pref., Japan
Fukui Chuoh Clinic | Fukui city, Fukui pref., Japan
Fukuoka City Medical Association Hospital | Fukuoka city, Fukuoka pref., Japan
Matsumoto Clinic | Fukuoka city, Fukuoka pref., Japan
Saku Hospital | Fukuoka city, Fukuoka pref., Japan
Soejima Medical Clinic | Fukuoka city, Fukuoka pref., Japan
Takei's Clinic Internal Medicine | Fukuoka city, Fukuoka pref., Japan
Nakamura Cardiovascular Clinic | Itoshima city, Fukuoka pref., Japan
Morizono Naika | Kitakyushu city, Fukuoka pref., Japan
Seino Internal Medicine Clinic | Koriyama city, Fukushima pref., Japan
Kawade Iin | Gifu city, Gifu pref., Japan, Japan
Hashimoto Naika Clinic | Gifu city, Gifu pref., Japan
Iinuma Iin | Gifu city, Gifu pref., Japan
Ishimura Clinic | Gifu city, Gifu pref., Japan
Kawai Clinic | Gifu city, Gifu pref., Japan
Niimi Clinic | Gifu city, Gifu pref., Japan
Takai Clinic | Gifu city, Gifu pref., Japan
Kobayashi Internal Medicine | Kakamigahara city, Gifu pref., Japan
Horibe Clinic | Motosu city, Gifu pref., Japan
Kondo Cardiovascular Clinic | Ogaki, Gifu pref., Japan
Yoshida Naika | Ogaki, Gifu pref., Japan
Kogure Clinic | Maebashi city, Gunma pref., Japan
Nakano Clinic | Shibukawa city, Gunma pref., Japan
Yoshii Central Clinic | Takasaki city, Gunma pref., Japan
Shigenobu Clinic | Miyoshi city, Hiroshima pref., Japan
Takahashi Kiyohito Clinic | Hakodate city, Hokkaido pref., Japan
Hokuto Internal Medicine Clinic | Sapporo city, Hokkaido pref., Japan
Katsuya Clinic | Amagasaki city, Hyogo pref., Japan
Nakatani Hospital | Himeji city, Hyogo pref., Japan
Kosumo Clinic | Kako gun, Hyogo pref., Japan
Harima Clinic | Kakogawa, Hyogo pref., Japan
Kusunose Clinic | Kobe city, Hyogo pref., Japan
Yanagi Medical Clinic | Hakusan city, Ishikawa pref., Japan
Okyozuka Clinic | Ishikawa gun, Ishikawa pref., Japan
Doniwa Clinic | Kanazawa city, Ishikawa pref., Japan
Wakasa Medical Clinic | Kanazawa city, Ishikawa pref., Japan
Association Medical Corporation Neurology Internal Medicine Kanamori Clinic | Iwate gun, Iwate pref., Japan
Medical Corporation Kuon-kai Kamata Medical Clinic | Morioka city, Iwate pref., Japan
Kagawa Clinic | Marugame city, Kagawa pref., Japan
Hasegawa Outpatients Clinic for Cardiovascular Disease | Takamatsu city, Kagawa pref., Japan
Tempozan Naika Clinic | Kagoshima city, Kagoshima pref., Japan
Kashiwagi Clinic | Ayase city, Kanagawa pref., Japan
Hayashi Diabetes Clinic | Chigasaki city, Kanagawa pref., Japan
Takada Internal Medicine Clinic | Hiratsuka city, Kanagawa pref., Japan
Iroden Clinic | Kamakura city, Kanagawa pref., Japan
Nagasu Clinic | Kamakura city, Kanagawa pref., Japan
Kobayashi Hospital | Odawara city, Kanagawa pref., Japan
Hakuai Iin | Sagamihara city, Kanagawa pref., Japan
Yamamoto Clinic | Sagamihara city, Kanagawa pref., Japan
Arima Clinic | Yokohama city, Kanagawa pref., Japan
Kikuchi Clinic | Yokohama city, Kanagawa pref., Japan
Miho cho Cardiovascular Medical Clinic | Yokohama city, Kanagawa pref., Japan
Minamisawa Clinic | Yokohama city, Kanagawa pref., Japan
Shimokurata Heart Clinic | Yokohama city, Kanagawa pref., Japan
Yokohama Sotetsu Bldg. Clinic of Internal Medicine | Yokohama city, Kanagawa pref., Japan
Jinnouchi Clinic Diabetes Care Center | Kumamoto city, Kumamoto pref., Japan
Maki Cardiovascular Clinic | Kumamoto city, Kumamoto pref., Japan
Munakata Clinic | Kumamoto city, Kumamoto pref., Japan
Terao Hospital | Kumamoto city, Kumamoto pref., Japan
Higashi Diabetes and Cardiovascular Clinic | Tamana city, Kumamoto pref., Japan
Matsuo Clinic | Tamana city, Kumamoto pref., Japan
Miyagi Clinic Cardiovascular Medicine | Yatsushiro city, Kumamoto pref., Japan
Sawai Naika Iin | Kyotanabe city, Kyoto pref., Japan
Asamoto Internal Medical Clinic | Kyoto city, Kyoto pref., Japan
Ijinkai Takeda General Hospital | Kyoto city, Kyoto pref., Japan
Koseikai Clinic | Kyoto city, Kyoto pref., Japan
Sakabe International Clinic | Kyoto city, Kyoto pref., Japan
Takenaka Clinic | Kyoto city, Kyoto pref., Japan
Tegoshi Clinic | Kyoto city, Kyoto pref., Japan
Iwasaki Hospital | Tsu city, Mie pref., Japan
Ishikawa Clinic | Miyazaki city, Miyazaki pref., Japan
Yokota Naika | Miyazaki city, Miyazaki pref., Japan
Etou Clinic | Nichinan city, Miyazaki pref., Japan
Kawano Clinic | Nichinan city, Miyazaki pref., Japan
Yamaguchi Clinic | Nichinan city, Miyazaki pref., Japan
Hasegawa Clinic | Nakano city, Nagano pref., Japan
Nara Prefectural Gojo Hospital | Gojo city, Nara pref., Japan
Fujii Internal Medicine Clinic | Kashihara city, Nara pref., Japan
Matsuoka Clinic | Kita katsuragi gun, Nara pref., Japan
Ote Clinic of Internal | Sakurai city, Nara pref., Japan
Uchiyama Clinic | Joetsu city, Niigata pref., Japan
Inoue Clinic | Niigata city, Niigata pref., Japan
Maeda Medical Clinic | Niigata city, Niigata pref., Japan
Nishimura Clinic | Fujiidera city, Osaka pref., Japan
Shoseikai Matsuda Iin | Fujiidera city, Osaka pref., Japan
Ikeda Clinic | Higashiosaka city, Osaka pref., Japan
Kanazawa Clinic | Izumi city, Osaka pref., Japan
Fukuda Clinic | Osaka city, Osaka pref., Japan
Jikuhara Clinic | Osaka city, Osaka pref., Japan
Kawagishi-naika Clinic | Osaka city, Osaka pref., Japan
Kinugawa Cardiology Clinic | Osaka city, Osaka pref., Japan
Kubota Clinic | Osaka city, Osaka pref., Japan
Masaki Clinic | Osaka city, Osaka pref., Japan
Nanko Clinic | Osaka city, Osaka pref., Japan
Osaka Ekisaikai Hospital | Osaka city, Osaka pref., Japan
Tamatani Clinic | Osaka city, Osaka pref., Japan
Hayashi Clinic | Sakai city, Osaka pref., Japan
Nakao Medical Clinic | Sakai city, Osaka pref., Japan
Saga Memorial Clinic | Saga city, Saga pref., Japan
Enomoto Clinic | Ageo city, Saitama pref., Japan
Asano Internal Medicine Clinic | Kawagoe city, Saitama pref., Japan
Iryohojin Hogi Sinryojyo | Kawaguchi city, Saitama pref., Japan
Tokutake Iin | Kawaguchi city, Saitama pref., Japan
Medical Corporation Shibuya Clinic | Kumagaya city, Saitama pref., Japan
Tanaka Medical Clinic | Saitama city, Saitama pref., Japan
Yoshimura Eye&Internal Medical Clinic | Mishima city, Shizuoka pref., Japan
Shizuoka Municipal Hospital | Shizuoka city, Shizuoka pref., Japan
Takada Clinic | Tochigi city, Tochigi pref., Japan
Murakami Clinic | Anan city, Tokushima pref., Japan
Ota Clinic | Awa city, 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 city, Tokushima pref., Japan
Iryohojin Tokujikai Tanaka Iin | Myozai gun, Tokushima pref., Japan
Kensei Uchimachi Clinic | Tokushima city, Tokushima pref., Japan
Yata Clinic | Yoshinogawa city, 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 city, Tokyo, Japan
Ayame Medical Clinic | Shimonoseki city, Yamaguchi pref., Japan
Matsuda Medical Clinic | Shimonoseki city, Yamaguchi pref., Japan
Mizumachi Medical Clinic | Shimonoseki city, Yamaguchi pref., Japan
Kuroda Iin | Otsuki city, Yamanashi pref., Japan
Yasue Naika | Gifu city, Japan
Location Countries

Japan

Verification Date

2015-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Atorvastatin administration group

Type: Experimental

Label: Rosuvastatin administration group

Type: Experimental

Acronym LISTEN
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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