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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,049

participants targeted

Target at P75+ for not_applicable

Geographic Reach

1 country

133 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed

7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed

10 months until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed

Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

February 23, 2012

Results QC Date

November 10, 2014

Last Update Submit

March 4, 2015

Conditions

Hypercholesterolemia With Concomitant Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

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 Outcomes (15)

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）
+10 more secondary outcomes

Study Arms (2)

Atorvastatin administration group

EXPERIMENTAL

Drug: Atorvastatin

Rosuvastatin administration group

EXPERIMENTAL

Drug: Rosuvastatin

Interventions

AtorvastatinDRUG

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.)

Also known as: Lipitor

Atorvastatin administration group

RosuvastatinDRUG

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.)

Also known as: Crestor

Rosuvastatin administration group

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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"
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
Patients giving voluntary written consent to participate in the study
Male or female patients at 20 years or older

You may not qualify if:

Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration
Patients with severe hypertension (systolic blood pressure \[SBP\] ≥ 180 mmHg or diastolic blood pressure \[DBP\] ≥ 110 mmHg)
Patients with type 1 diabetes
Patients judged to have familial hypercholesterolemia
Patients with a serum triglyceride level of ≥ 400 mg/dL
Patients who had the onset of cardiovascular or cerebrovascular disease within three months
Patients with serious heart failure (NYHA classification III - IV)
Patients with a history of hypersensitivity to statins
Patients with a history of drug-induced myopathy
Patients with severe complication of diabetes
Patients receiving insulin
Patients with serious liver or kidney disease
Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan
Patients who are or may be pregnant
Patients judged by the investigators to be ineligible for participation in the study for any other reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Listen Trial Grouplead

Study Sites (133)

Hiramitsu Heart Clinic

Nagoya, Aichi Pref., Japan

Location

Honjo Daiichi Hospital

Yurihonjō, Akita Pref., Japan

Location

Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin

Matsudo, Chiba Pref., Japan

Location

Matsuno Medical Clinic

Iyo Gun, Ehime Pref., Japan

Location

Ishite Matsumoto Naika Junkanki Clinic

Matsuyama, Ehime Pref., Japan

Location

Ehime Medical CO OP Izumigawa Clinic

Niihama, Ehime Pref., Japan

Location

Fukui Chuoh Clinic

Fukui, Fukui Pref., Japan

Location

Fukuoka City Medical Association Hospital

Fukuoka, Fukuoka Pref., Japan

Location

Matsumoto Clinic

Fukuoka, Fukuoka Pref., Japan

Location

Saku Hospital

Fukuoka, Fukuoka Pref., Japan

Location

Soejima Medical Clinic

Fukuoka, Fukuoka Pref., Japan

Location

Takei's Clinic Internal Medicine

Fukuoka, Fukuoka Pref., Japan

Location

Nakamura Cardiovascular Clinic

Itoshima, Fukuoka Pref., Japan

Location

Morizono Naika

Kitakyushu, Fukuoka Pref., Japan

Location

Seino Internal Medicine Clinic

Kōriyama, Fukushima Pref., Japan

Location

Yasue Naika

Gifu, Gifu City, Japan

Location

Kawade Iin

Gifu, Gifu Pref., Japan, Japan

Location

Hashimoto Naika Clinic

Gifu, Gifu Pref., Japan

Location

Iinuma Iin

Gifu, Gifu Pref., Japan

Location

Ishimura Clinic

Gifu, Gifu Pref., Japan

Location

Kawai Clinic

Gifu, Gifu Pref., Japan

Location

Niimi Clinic

Gifu, Gifu Pref., Japan

Location

Takai Clinic

Gifu, Gifu Pref., Japan

Location

Kobayashi Internal Medicine

Kakamigahara, Gifu Pref., Japan

Location

Horibe Clinic

Motosu, Gifu Pref., Japan

Location

Kondo Cardiovascular Clinic

Ōgaki, Gifu Pref., Japan

Location

Yoshida Naika

Ōgaki, Gifu Pref., Japan

Location

Kogure Clinic

Maebashi, Gunma Pref., Japan

Location

Nakano Clinic

Shibukawa, Gunma Pref., Japan

Location

Yoshii Central Clinic

Takasaki, Gunma Pref., Japan

Location

Shigenobu Clinic

Miyoshi, Hiroshima Pref., Japan

Location

Takahashi Kiyohito Clinic

Hakodate, Hokkaido Pref., Japan

Location

Hokuto Internal Medicine Clinic

Sapporo, Hokkaido Pref., Japan

Location

Katsuya Clinic

Amagasaki, Hyogo Pref., Japan

Location

Nakatani Hospital

Himeji, Hyogo Pref., Japan

Location

Kosumo Clinic

Kako Gun, Hyogo Pref., Japan

Location

Harima Clinic

Kakogawa, Hyogo Pref., Japan

Location

Kusunose Clinic

Kobe, Hyogo Pref., Japan

Location

Yanagi Medical Clinic

Hakusan, Ishikawa Pref., Japan

Location

Okyozuka Clinic

Ishikawa Gun, Ishikawa Pref., Japan

Location

Doniwa Clinic

Kanazawa, Ishikawa Pref., Japan

Location

Wakasa Medical Clinic

Kanazawa, Ishikawa Pref., Japan

Location

Association Medical Corporation Neurology Internal Medicine Kanamori Clinic

Iwate Gun, Iwate Pref., Japan

Location

Medical Corporation Kuon-kai Kamata Medical Clinic

Morioka, Iwate Pref., Japan

Location

Kagawa Clinic

Marugame, Kagawa Pref., Japan

Location

Hasegawa Outpatients Clinic for Cardiovascular Disease

Takamatsu, Kagawa Pref., Japan

Location

Tempozan Naika Clinic

Kagoshima, Kagoshima Pref., Japan

Location

Kashiwagi Clinic

Ayase, Kanagawa Pref., Japan

Location

Hayashi Diabetes Clinic

Chigasaki, Kanagawa Pref., Japan

Location

Takada Internal Medicine Clinic

Hiratsuka, Kanagawa Pref., Japan

Location

Iroden Clinic

Kamakura, Kanagawa Pref., Japan

Location

Nagasu Clinic

Kamakura, Kanagawa Pref., Japan

Location

Kobayashi Hospital

Odawara, Kanagawa Pref., Japan

Location

Hakuai Iin

Sagamihara, Kanagawa Pref., Japan

Location

Yamamoto Clinic

Sagamihara, Kanagawa Pref., Japan

Location

Arima Clinic