Clinical trial NCT01544309: LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
Official title: Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes
Lead sponsor: Listen Trial Group
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 1049
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
timeFrame: Baseline, and 12 months after administration
measure: Change in HbA1c Level
timeFrame: Baseline, 12 months after administration
Secondary outcomes:
measure: Occurrence of Deterioration of Diabetic Treatment Status
timeFrame: Baseline, 12 months after administration
measure: Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status
timeFrame: Baseline, 3, 6, 12 months after administration
measure: Percent Change in 1,5-AG Level
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
measure: Change in HbA1c Level
timeFrame: Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
measure: Percent Change in Blood Glucose Level (Fasting)
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
measure: Change in Blood Glucose Level (Fasting)
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
measure: Percent Change in Insulin Level
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
measure: Change From Baseline in Insulin Level
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）
measure: Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)
timeFrame: From the start of the treatment to the end of study treatment
measure: Frequency of Serious Adverse Events (SAE)
timeFrame: Up to 12 months
measure: Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)
timeFrame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
measure: Percent Change in Non-HDL-C Level
timeFrame: Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment
measure: Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation
timeFrame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
measure: Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007
timeFrame: 3 months after administration, the end of starting dose and the end of study treatment
measure: Change From Baseline in 1,5-AG Level
timeFrame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
Other outcomes:
Locations:
city: Nagoya city
country: Japan
facility: Hiramitsu Heart Clinic
state: Aichi pref.
city: Yurihonjo city
country: Japan
facility: Honjo Daiichi Hospital
state: Akita pref.
city: Matsudo city
country: Japan
facility: Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin
state: Chiba pref.
city: Iyo gun
country: Japan
facility: Matsuno Medical Clinic
state: Ehime pref.
city: Matsuyama city
country: Japan
facility: Ishite Matsumoto Naika Junkanki Clinic
state: Ehime pref.
city: Niihama city
country: Japan
facility: Ehime Medical CO OP Izumigawa Clinic
state: Ehime pref.
city: Fukui city
country: Japan
facility: Fukui Chuoh Clinic
state: Fukui pref.
city: Fukuoka city
country: Japan
facility: Fukuoka City Medical Association Hospital
state: Fukuoka pref.
city: Fukuoka city
country: Japan
facility: Matsumoto Clinic
state: Fukuoka pref.
city: Fukuoka city
country: Japan
facility: Saku Hospital
state: Fukuoka pref.
city: Fukuoka city
country: Japan
facility: Soejima Medical Clinic
state: Fukuoka pref.
city: Fukuoka city
country: Japan
facility: Takei's Clinic Internal Medicine
state: Fukuoka pref.
city: Itoshima city
country: Japan
facility: Nakamura Cardiovascular Clinic
state: Fukuoka pref.
city: Kitakyushu city
country: Japan
facility: Morizono Naika
state: Fukuoka pref.
city: Koriyama city
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima pref.
city: Gifu city
country: Japan
facility: Kawade Iin
state: Gifu pref.
city: Gifu city
country: Japan
facility: Hashimoto Naika Clinic
state: Gifu pref.
city: Gifu city
country: Japan
facility: Iinuma Iin
state: Gifu pref.
city: Gifu city
country: Japan
facility: Ishimura Clinic
state: Gifu pref.
city: Gifu city
country: Japan
facility: Kawai Clinic
state: Gifu pref.
city: Gifu city
country: Japan
facility: Niimi Clinic
state: Gifu pref.
city: Gifu city
country: Japan
facility: Takai Clinic
state: Gifu pref.
city: Kakamigahara city
country: Japan
facility: Kobayashi Internal Medicine
state: Gifu pref.
city: Motosu city
country: Japan
facility: Horibe Clinic
state: Gifu pref.
city: Ogaki
country: Japan
facility: Kondo Cardiovascular Clinic
state: Gifu pref.
city: Ogaki
country: Japan
facility: Yoshida Naika
state: Gifu pref.
city: Maebashi city
country: Japan
facility: Kogure Clinic
state: Gunma pref.
city: Shibukawa city
country: Japan
facility: Nakano Clinic
state: Gunma pref.
city: Takasaki city
country: Japan
facility: Yoshii Central Clinic
state: Gunma pref.
city: Miyoshi city
country: Japan
facility: Shigenobu Clinic
state: Hiroshima pref.
city: Hakodate city
country: Japan
facility: Takahashi Kiyohito Clinic
state: Hokkaido pref.
city: Sapporo city
country: Japan
facility: Hokuto Internal Medicine Clinic
state: Hokkaido pref.
city: Amagasaki city
country: Japan
facility: Katsuya Clinic
state: Hyogo pref.
city: Himeji city
country: Japan
facility: Nakatani Hospital
state: Hyogo pref.
city: Kako gun
country: Japan
facility: Kosumo Clinic
state: Hyogo pref.
city: Kakogawa
country: Japan
facility: Harima Clinic
state: Hyogo pref.
city: Kobe city
country: Japan
facility: Kusunose Clinic
state: Hyogo pref.
city: Hakusan city
country: Japan
facility: Yanagi Medical Clinic
state: Ishikawa pref.
city: Ishikawa gun
country: Japan
facility: Okyozuka Clinic
state: Ishikawa pref.
city: Kanazawa city
country: Japan
facility: Doniwa Clinic
state: Ishikawa pref.
city: Kanazawa city
country: Japan
facility: Wakasa Medical Clinic
state: Ishikawa pref.
city: Iwate gun
country: Japan
facility: Association Medical Corporation Neurology Internal Medicine Kanamori Clinic
state: Iwate pref.
city: Morioka city
country: Japan
facility: Medical Corporation Kuon-kai Kamata Medical Clinic
state: Iwate pref.
city: Marugame city
country: Japan
facility: Kagawa Clinic
state: Kagawa pref.
city: Takamatsu city
country: Japan
facility: Hasegawa Outpatients Clinic for Cardiovascular Disease
state: Kagawa pref.
city: Kagoshima city
country: Japan
facility: Tempozan Naika Clinic
state: Kagoshima pref.
city: Ayase city
country: Japan
facility: Kashiwagi Clinic
state: Kanagawa pref.
city: Chigasaki city
country: Japan
facility: Hayashi Diabetes Clinic
state: Kanagawa pref.
city: Hiratsuka city
country: Japan
facility: Takada Internal Medicine Clinic
state: Kanagawa pref.
city: Kamakura city
country: Japan
facility: Iroden Clinic
state: Kanagawa pref.
city: Kamakura city
country: Japan
facility: Nagasu Clinic
state: Kanagawa pref.
city: Odawara city
country: Japan
facility: Kobayashi Hospital
state: Kanagawa pref.
city: Sagamihara city
country: Japan
facility: Hakuai Iin
state: Kanagawa pref.
city: Sagamihara city
country: Japan
facility: Yamamoto Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Arima Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Kikuchi Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Miho cho Cardiovascular Medical Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Minamisawa Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Shimokurata Heart Clinic
state: Kanagawa pref.
city: Yokohama city
country: Japan
facility: Yokohama Sotetsu Bldg. Clinic of Internal Medicine
state: Kanagawa pref.
city: Kumamoto city
country: Japan
facility: Jinnouchi Clinic Diabetes Care Center
state: Kumamoto pref.
city: Kumamoto city
country: Japan
facility: Maki Cardiovascular Clinic
state: Kumamoto pref.
city: Kumamoto city
country: Japan
facility: Munakata Clinic
state: Kumamoto pref.
city: Kumamoto city
country: Japan
facility: Terao Hospital
state: Kumamoto pref.
city: Tamana city
country: Japan
facility: Higashi Diabetes and Cardiovascular Clinic
state: Kumamoto pref.
city: Tamana city
country: Japan
facility: Matsuo Clinic
state: Kumamoto pref.
city: Yatsushiro city
country: Japan
facility: Miyagi Clinic Cardiovascular Medicine
state: Kumamoto pref.
city: Kyotanabe city
country: Japan
facility: Sawai Naika Iin
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Asamoto Internal Medical Clinic
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Ijinkai Takeda General Hospital
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Koseikai Clinic
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Sakabe International Clinic
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Takenaka Clinic
state: Kyoto pref.
city: Kyoto city
country: Japan
facility: Tegoshi Clinic
state: Kyoto pref.
city: Tsu city
country: Japan
facility: Iwasaki Hospital
state: Mie pref.
city: Miyazaki city
country: Japan
facility: Ishikawa Clinic
state: Miyazaki pref.
city: Miyazaki city
country: Japan
facility: Yokota Naika
state: Miyazaki pref.
city: Nichinan city
country: Japan
facility: Etou Clinic
state: Miyazaki pref.
city: Nichinan city
country: Japan
facility: Kawano Clinic
state: Miyazaki pref.
city: Nichinan city
country: Japan
facility: Yamaguchi Clinic
state: Miyazaki pref.
city: Nakano city
country: Japan
facility: Hasegawa Clinic
state: Nagano pref.
city: Gojo city
country: Japan
facility: Nara Prefectural Gojo Hospital
state: Nara pref.
city: Kashihara city
country: Japan
facility: Fujii Internal Medicine Clinic
state: Nara pref.
city: Kita katsuragi gun
country: Japan
facility: Matsuoka Clinic
state: Nara pref.
city: Sakurai city
country: Japan
facility: Ote Clinic of Internal
state: Nara pref.
city: Joetsu city
country: Japan
facility: Uchiyama Clinic
state: Niigata pref.
city: Niigata city
country: Japan
facility: Inoue Clinic
state: Niigata pref.
city: Niigata city
country: Japan
facility: Maeda Medical Clinic
state: Niigata pref.
city: Fujiidera city
country: Japan
facility: Nishimura Clinic
state: Osaka pref.
city: Fujiidera city
country: Japan
facility: Shoseikai Matsuda Iin
state: Osaka pref.
city: Higashiosaka city
country: Japan
facility: Ikeda Clinic
state: Osaka pref.
city: Izumi city
country: Japan
facility: Kanazawa Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Fukuda Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Jikuhara Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Kawagishi-naika Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Kinugawa Cardiology Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Kubota Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Masaki Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Nanko Clinic
state: Osaka pref.
city: Osaka city
country: Japan
facility: Osaka Ekisaikai Hospital
state: Osaka pref.
city: Osaka city
country: Japan
facility: Tamatani Clinic
state: Osaka pref.
city: Sakai city
country: Japan
facility: Hayashi Clinic
state: Osaka pref.
city: Sakai city
country: Japan
facility: Nakao Medical Clinic
state: Osaka pref.
city: Saga city
country: Japan
facility: Saga Memorial Clinic
state: Saga pref.
city: Ageo city
country: Japan
facility: Enomoto Clinic
state: Saitama pref.
city: Kawagoe city
country: Japan
facility: Asano Internal Medicine Clinic
state: Saitama pref.
city: Kawaguchi city
country: Japan
facility: Iryohojin Hogi Sinryojyo
state: Saitama pref.
city: Kawaguchi city
country: Japan
facility: Tokutake Iin
state: Saitama pref.
city: Kumagaya city
country: Japan
facility: Medical Corporation Shibuya Clinic
state: Saitama pref.
city: Saitama city
country: Japan
facility: Tanaka Medical Clinic
state: Saitama pref.
city: Mishima city
country: Japan
facility: Yoshimura Eye&Internal Medical Clinic
state: Shizuoka pref.
city: Shizuoka city
country: Japan
facility: Shizuoka Municipal Hospital
state: Shizuoka pref.
city: Tochigi city
country: Japan
facility: Takada Clinic
state: Tochigi pref.
city: Anan city
country: Japan
facility: Murakami Clinic
state: Tokushima pref.
city: Awa city
country: Japan
facility: Ota Clinic
state: Tokushima pref.
city: Itano gun
country: Japan
facility: Arizumi Clinic
state: Tokushima pref.
city: Kaifu gun
country: Japan
facility: Yuki National Health Insurance Hospital of Minami Town
state: Tokushima pref.
city: Komatsushima city
country: Japan
facility: Sekishinkan Hospital
state: Tokushima pref.
city: Myozai gun
country: Japan
facility: Iryohojin Tokujikai Tanaka Iin
state: Tokushima pref.
city: Tokushima city
country: Japan
facility: Kensei Uchimachi Clinic
state: Tokushima pref.
city: Yoshinogawa city
country: Japan
facility: Yata Clinic
state: Tokushima pref.
city: Chuo ku
country: Japan
facility: Tokyo Center Clinic
state: Tokyo
city: Katsushika ku
country: Japan
facility: Okudo Poly Clinic
state: Tokyo
city: Nakano ku
country: Japan
facility: Nakano Sunbright Clinic
state: Tokyo
city: Nerima ku
country: Japan
facility: Sugawara Clinic
state: Tokyo
city: Setagaya ku
country: Japan
facility: Tsurumachi Clinic
state: Tokyo
city: Shinjuku ku
country: Japan
facility: Oda Clinic
state: Tokyo
city: Tachikawa city
country: Japan
facility: Ishii Clinic
state: Tokyo
city: Shimonoseki city
country: Japan
facility: Ayame Medical Clinic
state: Yamaguchi pref.
city: Shimonoseki city
country: Japan
facility: Matsuda Medical Clinic
state: Yamaguchi pref.
city: Shimonoseki city
country: Japan
facility: Mizumachi Medical Clinic
state: Yamaguchi pref.
city: Otsuki city
country: Japan
facility: Kuroda Iin
state: Yamanashi pref.
city: Gifu city
country: Japan
facility: Yasue Naika
Study officials:
affiliation: Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
name: Hisao Ogawa, Ph.D
role: STUDY_CHAIR
References:
citation: 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.