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

Hypercholesterolemia With Concomitant Type 2 Diabetes Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544309
• Other study ID #: 0059
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: March 4, 2015
• Start date: March 2012

Study information

• Verified date: March 2015
• Source: Listen Trial Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1049
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Hypercholesterolemia With Concomitant Type 2 Diabetes

Intervention

Drug:
• 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.)
• 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.)

Locations

Country	Name	City	State
Japan	Enomoto Clinic	Ageo city	Saitama pref.
Japan	Katsuya Clinic	Amagasaki city	Hyogo pref.
Japan	Murakami Clinic	Anan city	Tokushima pref.
Japan	Ota Clinic	Awa city	Tokushima pref.
Japan	Kashiwagi Clinic	Ayase city	Kanagawa pref.
Japan	Hayashi Diabetes Clinic	Chigasaki city	Kanagawa pref.
Japan	Tokyo Center Clinic	Chuo ku	Tokyo
Japan	Nishimura Clinic	Fujiidera city	Osaka pref.
Japan	Shoseikai Matsuda Iin	Fujiidera city	Osaka 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	Hashimoto Naika Clinic	Gifu city	Gifu pref.
Japan	Iinuma Iin	Gifu city	Gifu pref.
Japan	Ishimura Clinic	Gifu city	Gifu pref.
Japan	Kawade Iin	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	Yasue Naika	Gifu city
Japan	Nara Prefectural Gojo Hospital	Gojo city	Nara pref.
Japan	Takahashi Kiyohito Clinic	Hakodate city	Hokkaido pref.
Japan	Yanagi Medical Clinic	Hakusan city	Ishikawa pref.
Japan	Ikeda Clinic	Higashiosaka city	Osaka pref.
Japan	Nakatani Hospital	Himeji city	Hyogo pref.
Japan	Takada Internal Medicine Clinic	Hiratsuka city	Kanagawa pref.
Japan	Okyozuka Clinic	Ishikawa gun	Ishikawa pref.
Japan	Arizumi Clinic	Itano gun	Tokushima pref.
Japan	Nakamura Cardiovascular Clinic	Itoshima city	Fukuoka pref.
Japan	Association Medical Corporation Neurology Internal Medicine Kanamori Clinic	Iwate gun	Iwate pref.
Japan	Matsuno Medical Clinic	Iyo gun	Ehime pref.
Japan	Kanazawa Clinic	Izumi city	Osaka pref.
Japan	Uchiyama Clinic	Joetsu city	Niigata pref.
Japan	Tempozan Naika Clinic	Kagoshima city	Kagoshima pref.
Japan	Yuki National Health Insurance Hospital of Minami Town	Kaifu gun	Tokushima pref.
Japan	Kobayashi Internal Medicine	Kakamigahara city	Gifu pref.
Japan	Kosumo Clinic	Kako gun	Hyogo pref.
Japan	Harima Clinic	Kakogawa	Hyogo pref.
Japan	Iroden Clinic	Kamakura city	Kanagawa pref.
Japan	Nagasu Clinic	Kamakura city	Kanagawa pref.
Japan	Doniwa Clinic	Kanazawa city	Ishikawa pref.
Japan	Wakasa Medical Clinic	Kanazawa city	Ishikawa pref.
Japan	Fujii Internal Medicine Clinic	Kashihara city	Nara pref.
Japan	Okudo Poly Clinic	Katsushika ku	Tokyo
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	Matsuoka Clinic	Kita katsuragi gun	Nara pref.
Japan	Morizono Naika	Kitakyushu city	Fukuoka pref.
Japan	Kusunose Clinic	Kobe city	Hyogo pref.
Japan	Sekishinkan Hospital	Komatsushima city	Tokushima pref.
Japan	Seino Internal Medicine Clinic	Koriyama city	Fukushima pref.
Japan	Medical Corporation Shibuya Clinic	Kumagaya city	Saitama 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	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	Kogure Clinic	Maebashi city	Gunma pref.
Japan	Kagawa Clinic	Marugame city	Kagawa pref.
Japan	Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin	Matsudo city	Chiba pref.
Japan	Ishite Matsumoto Naika Junkanki Clinic	Matsuyama city	Ehime pref.
Japan	Yoshimura Eye&Internal Medical Clinic	Mishima city	Shizuoka pref.
Japan	Ishikawa Clinic	Miyazaki city	Miyazaki pref.
Japan	Yokota Naika	Miyazaki city	Miyazaki pref.
Japan	Shigenobu Clinic	Miyoshi city	Hiroshima pref.
Japan	Medical Corporation Kuon-kai Kamata Medical Clinic	Morioka city	Iwate pref.
Japan	Horibe Clinic	Motosu city	Gifu pref.
Japan	Iryohojin Tokujikai Tanaka Iin	Myozai gun	Tokushima pref.
Japan	Hiramitsu Heart Clinic	Nagoya city	Aichi pref.
Japan	Hasegawa Clinic	Nakano city	Nagano pref.
Japan	Nakano Sunbright Clinic	Nakano ku	Tokyo
Japan	Sugawara Clinic	Nerima ku	Tokyo
Japan	Etou Clinic	Nichinan city	Miyazaki pref.
Japan	Kawano Clinic	Nichinan city	Miyazaki pref.
Japan	Yamaguchi Clinic	Nichinan city	Miyazaki pref.
Japan	Inoue Clinic	Niigata city	Niigata pref.
Japan	Maeda Medical Clinic	Niigata city	Niigata pref.
Japan	Ehime Medical CO OP Izumigawa Clinic	Niihama city	Ehime pref.
Japan	Kobayashi Hospital	Odawara city	Kanagawa pref.
Japan	Kondo Cardiovascular Clinic	Ogaki	Gifu pref.
Japan	Yoshida Naika	Ogaki	Gifu 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	Kuroda Iin	Otsuki city	Yamanashi pref.
Japan	Saga Memorial Clinic	Saga city	Saga pref.
Japan	Hakuai Iin	Sagamihara city	Kanagawa pref.
Japan	Yamamoto Clinic	Sagamihara city	Kanagawa pref.
Japan	Tanaka Medical Clinic	Saitama city	Saitama pref.
Japan	Hayashi Clinic	Sakai city	Osaka pref.
Japan	Nakao Medical Clinic	Sakai city	Osaka pref.
Japan	Ote Clinic of Internal	Sakurai city	Nara pref.
Japan	Hokuto Internal Medicine Clinic	Sapporo city	Hokkaido pref.
Japan	Tsurumachi Clinic	Setagaya ku	Tokyo
Japan	Nakano Clinic	Shibukawa city	Gunma pref.
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	Oda Clinic	Shinjuku ku	Tokyo
Japan	Shizuoka Municipal Hospital	Shizuoka city	Shizuoka pref.
Japan	Ishii Clinic	Tachikawa city	Tokyo
Japan	Hasegawa Outpatients Clinic for Cardiovascular Disease	Takamatsu city	Kagawa pref.
Japan	Yoshii Central Clinic	Takasaki city	Gunma pref.
Japan	Higashi Diabetes and Cardiovascular Clinic	Tamana city	Kumamoto pref.
Japan	Matsuo Clinic	Tamana city	Kumamoto pref.
Japan	Takada Clinic	Tochigi city	Tochigi pref.
Japan	Kensei Uchimachi Clinic	Tokushima city	Tokushima pref.
Japan	Iwasaki Hospital	Tsu city	Mie pref.
Japan	Miyagi Clinic Cardiovascular Medicine	Yatsushiro city	Kumamoto 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	Yata Clinic	Yoshinogawa city	Tokushima pref.
Japan	Honjo Daiichi Hospital	Yurihonjo city	Akita pref.

Sponsors (1)

Lead Sponsor	Collaborator
Listen Trial Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level		Baseline, and 12 months after administration	No
Primary	Change in HbA1c Level		Baseline, 12 months after administration	Yes
Secondary	Occurrence of Deterioration of Diabetic Treatment Status	"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.	Baseline, 12 months after administration	Yes
Secondary	Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status	"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.	Baseline, 3, 6, 12 months after administration	Yes
Secondary	Percent Change in 1,5-AG Level	An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa	Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	Percent Change in Insulin Level	An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.	Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)	Yes
Secondary	Change From Baseline in Insulin Level	An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa	Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)	Yes
Secondary	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	Yes
Secondary	Frequency of Serious Adverse Events (SAE)		Up to 12 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation	Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)	Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment	No
Secondary	Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007	Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.	3 months after administration, the end of starting dose and the end of study treatment	No
Secondary	Change From Baseline in 1,5-AG Level	An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa	Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)	Yes