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Hypercholesterolemia With Concomitant Type 2 DiabetesLISTENNCT01544309

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

A study testing Atorvastatin and Rosuvastatin in people with Hypercholesterolemia With Concomitant Type 2 Diabetes, run by Listen Trial Group at 133 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Atorvastatin and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,049 participants
Where
133 sitesJapan
Study dates
Mar 2012to Jun 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

133 sites in 1 country.

133 sites in 1 country

Japan133 sites

  • Enomoto Clinic

    Ageo, Saitama Pref.

  • Katsuya Clinic

    Amagasaki, Hyogo Pref.

  • Murakami Clinic

    Anan, Tokushima Pref.

  • Ota Clinic

    Awa, Tokushima Pref.

  • Kashiwagi Clinic

    Ayase, Kanagawa Pref.

  • Hayashi Diabetes Clinic

    Chigasaki, Kanagawa Pref.

  • Tokyo Center Clinic

    Chuo Ku, Tokyo

  • Nishimura Clinic

    Fujiidera, Osaka Pref.

  • Shoseikai Matsuda Iin

    Fujiidera, Osaka Pref.

  • Fukui Chuoh Clinic

    Fukui, Fukui Pref.

  • Fukuoka City Medical Association Hospital

    Fukuoka, Fukuoka Pref.

  • Matsumoto Clinic

    Fukuoka, Fukuoka Pref.

  • Saku Hospital

    Fukuoka, Fukuoka Pref.

  • Soejima Medical Clinic

    Fukuoka, Fukuoka Pref.

  • Takei's Clinic Internal Medicine

    Fukuoka, Fukuoka Pref.

  • Yasue Naika

    Gifu, Gifu City

  • Kawade Iin

    Gifu, Gifu Pref., Japan

  • Hashimoto Naika Clinic

    Gifu, Gifu Pref.

  • Iinuma Iin

    Gifu, Gifu Pref.

  • Ishimura Clinic

    Gifu, Gifu Pref.

  • Kawai Clinic

    Gifu, Gifu Pref.

  • Niimi Clinic

    Gifu, Gifu Pref.

  • Takai Clinic

    Gifu, Gifu Pref.

  • Nara Prefectural Gojo Hospital

    Gojō, Nara Pref.

  • Takahashi Kiyohito Clinic

    Hakodate, Hokkaido Pref.

  • Yanagi Medical Clinic

    Hakusan, Ishikawa Pref.

  • Ikeda Clinic

    Higashiosaka, Osaka Pref.

  • Nakatani Hospital

    Himeji, Hyogo Pref.

  • Takada Internal Medicine Clinic

    Hiratsuka, Kanagawa Pref.

  • Okyozuka Clinic

    Ishikawa Gun, Ishikawa Pref.

  • Arizumi Clinic

    Itano Gun, Tokushima Pref.

  • Nakamura Cardiovascular Clinic

    Itoshima, Fukuoka Pref.

  • Association Medical Corporation Neurology Internal Medicine Kanamori Clinic

    Iwate Gun, Iwate Pref.

  • Matsuno Medical Clinic

    Iyo Gun, Ehime Pref.

  • Kanazawa Clinic

    Izumi, Osaka Pref.

  • Uchiyama Clinic

    Jōetsu, Niigata Pref.

  • Tempozan Naika Clinic

    Kagoshima, Kagoshima Pref.

  • Yuki National Health Insurance Hospital of Minami Town

    Kaifu Gun, Tokushima Pref.

  • Kobayashi Internal Medicine

    Kakamigahara, Gifu Pref.

  • Kosumo Clinic

    Kako Gun, Hyogo Pref.

  • Harima Clinic

    Kakogawa, Hyogo Pref.

  • Iroden Clinic

    Kamakura, Kanagawa Pref.

  • Nagasu Clinic

    Kamakura, Kanagawa Pref.

  • Doniwa Clinic

    Kanazawa, Ishikawa Pref.

  • Wakasa Medical Clinic

    Kanazawa, Ishikawa Pref.

  • Fujii Internal Medicine Clinic

    Kashihara, Nara Pref.

  • Okudo Poly Clinic

    Katsushika-ku, Tokyo

  • Asano Internal Medicine Clinic

    Kawagoe, Saitama Pref.

  • Iryohojin Hogi Sinryojyo

    Kawaguchi, Saitama Pref.

  • Tokutake Iin

    Kawaguchi, Saitama Pref.

  • Matsuoka Clinic

    Kita Katsuragi Gun, Nara Pref.

  • Morizono Naika

    Kitakyushu, Fukuoka Pref.

  • Kusunose Clinic

    Kobe, Hyogo Pref.

  • Sekishinkan Hospital

    Komatsushima, Tokushima Pref.

  • Seino Internal Medicine Clinic

    Kōriyama, Fukushima Pref.

  • Medical Corporation Shibuya Clinic

    Kumagaya, Saitama Pref.

  • Jinnouchi Clinic Diabetes Care Center

    Kumamoto, Kumamoto Pref.

  • Maki Cardiovascular Clinic

    Kumamoto, Kumamoto Pref.

  • Munakata Clinic

    Kumamoto, Kumamoto Pref.

  • Terao Hospital

    Kumamoto, Kumamoto Pref.

  • Sawai Naika Iin

    Kyōtanabe, Kyoto Pref.

  • Asamoto Internal Medical Clinic

    Kyoto, Kyoto Pref.

  • Ijinkai Takeda General Hospital

    Kyoto, Kyoto Pref.

  • Koseikai Clinic

    Kyoto, Kyoto Pref.

  • Sakabe International Clinic

    Kyoto, Kyoto Pref.

  • Takenaka Clinic

    Kyoto, Kyoto Pref.

  • Tegoshi Clinic

    Kyoto, Kyoto Pref.

  • Kogure Clinic

    Maebashi, Gunma Pref.

  • Kagawa Clinic

    Marugame, Kagawa Pref.

  • Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin

    Matsudo, Chiba Pref.

  • Ishite Matsumoto Naika Junkanki Clinic

    Matsuyama, Ehime Pref.

  • Yoshimura Eye&Internal Medical Clinic

    Mishima, Shizuoka Pref.

  • Ishikawa Clinic

    Miyazaki, Miyazaki Pref.

  • Yokota Naika

    Miyazaki, Miyazaki Pref.

  • Shigenobu Clinic

    Miyoshi, Hiroshima Pref.

  • Medical Corporation Kuon-kai Kamata Medical Clinic

    Morioka, Iwate Pref.

  • Horibe Clinic

    Motosu, Gifu Pref.

  • Iryohojin Tokujikai Tanaka Iin

    Myozai Gun, Tokushima Pref.

  • Hiramitsu Heart Clinic

    Nagoya, Aichi Pref.

  • Hasegawa Clinic

    Nakano City, Nagano Pref.

  • Nakano Sunbright Clinic

    Nakano Ku, Tokyo

  • Sugawara Clinic

    Nerima Ku, Tokyo

  • Etou Clinic

    Nichinan, Miyazaki Pref.

  • Kawano Clinic

    Nichinan, Miyazaki Pref.

  • Yamaguchi Clinic

    Nichinan, Miyazaki Pref.

  • Inoue Clinic

    Niigata, Niigata Pref.

  • Maeda Medical Clinic

    Niigata, Niigata Pref.

  • Ehime Medical CO OP Izumigawa Clinic

    Niihama, Ehime Pref.

  • Kobayashi Hospital

    Odawara, Kanagawa Pref.

  • Kondo Cardiovascular Clinic

    Ōgaki, Gifu Pref.

  • Yoshida Naika

    Ōgaki, Gifu Pref.

  • Fukuda Clinic

    Osaka, Osaka Pref.

  • Jikuhara Clinic

    Osaka, Osaka Pref.

  • Kawagishi-naika Clinic

    Osaka, Osaka Pref.

  • Kinugawa Cardiology Clinic

    Osaka, Osaka Pref.

  • Kubota Clinic

    Osaka, Osaka Pref.

  • Masaki Clinic

    Osaka, Osaka Pref.

  • Nanko Clinic

    Osaka, Osaka Pref.

  • Osaka Ekisaikai Hospital

    Osaka, Osaka Pref.

  • Tamatani Clinic

    Osaka, Osaka Pref.

  • Kuroda Iin

    Ōtsuki, Yamanashi Pref.

  • Saga Memorial Clinic

    Saga, Saga Pref.

  • Hakuai Iin

    Sagamihara, Kanagawa Pref.

  • Yamamoto Clinic

    Sagamihara, Kanagawa Pref.

  • Tanaka Medical Clinic

    Saitama, Saitama Pref.

  • Hayashi Clinic

    Sakai, Osaka Pref.

  • Nakao Medical Clinic

    Sakai, Osaka Pref.

  • Ote Clinic of Internal

    Sakurai, Nara Pref.

  • Hokuto Internal Medicine Clinic

    Sapporo, Hokkaido Pref.

  • Tsurumachi Clinic

    Setagaya Ku, Tokyo

  • Nakano Clinic

    Shibukawa, Gunma Pref.

  • Ayame Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Matsuda Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Mizumachi Medical Clinic

    Shimonoseki, Yamaguchi Pref.

  • Oda Clinic

    Shinjuku Ku, Tokyo

  • Shizuoka Municipal Hospital

    Shizuoka, Shizuoka Pref.

  • Ishii Clinic

    Tachikawa, Tokyo

  • Hasegawa Outpatients Clinic for Cardiovascular Disease

    Takamatsu, Kagawa Pref.

  • Yoshii Central Clinic

    Takasaki, Gunma Pref.

  • Higashi Diabetes and Cardiovascular Clinic

    Tamana, Kumamoto Pref.

  • Matsuo Clinic

    Tamana, Kumamoto Pref.

  • Takada Clinic

    Tochigi, Tochigi Pref.

  • Kensei Uchimachi Clinic

    Tokushima, Tokushima Pref.

  • Iwasaki Hospital

    Tsu, Mie Pref.

  • Miyagi Clinic Cardiovascular Medicine

    Yatsushiro, Kumamoto Pref.

  • Arima Clinic

    Yokohama, Kanagawa Pref.

  • Kikuchi Clinic

    Yokohama, Kanagawa Pref.

  • Miho cho Cardiovascular Medical Clinic

    Yokohama, Kanagawa Pref.

  • Minamisawa Clinic

    Yokohama, Kanagawa Pref.

  • Shimokurata Heart Clinic

    Yokohama, Kanagawa Pref.

  • Yokohama Sotetsu Bldg. Clinic of Internal Medicine

    Yokohama, Kanagawa Pref.

  • Yata Clinic

    Yoshinogawa, Tokushima Pref.

  • Honjo Daiichi Hospital

    Yurihonjō, Akita Pref.

Other trials in Japan

About this study

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

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Lipitor

    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.)

  • RosuvastatinDrug

    Also called Crestor

    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.)

Study groups in NCT01544309
Study groupRoleWhat they receive
Atorvastatin administration groupExperimentalNot described
Receives: Drug: Atorvastatin
Rosuvastatin administration groupExperimentalNot described
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level

    Measured: Baseline, and 12 months after administration

  2. Change in HbA1c Level

    Measured: Baseline, 12 months after administration

Secondary outcomes (15)

  1. 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%.

    Measured: Baseline, 12 months after administration

  2. 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%.

    Measured: Baseline, 3, 6, 12 months after administration

  3. 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

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  4. Change in HbA1c Level

    Measured: Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  5. Percent Change in Blood Glucose Level (Fasting)

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  6. Change in Blood Glucose Level (Fasting)

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

  7. 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.

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  8. 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

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

  9. Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)

    Measured: From the start of the treatment to the end of study treatment

  10. Frequency of Serious Adverse Events (SAE)

    Measured: Up to 12 months

  11. Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)

    Measured: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

  12. Percent Change in Non-HDL-C Level

    Measured: Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment

  13. 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)

    Measured: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

  14. 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.

    Measured: 3 months after administration, the end of starting dose and the end of study treatment

  15. 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

    Measured: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,049 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544309
Sponsor's protocol ID
0059
Acronym
LISTEN
Status last verified
Mar 2015
First submitted
23 Feb 2012
Last updated
17 Mar 2015

Publications

  • 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.

    PubMed 25186922

Questions about this trial

What is this clinical trial studying?

A study testing Atorvastatin and Rosuvastatin in people with Hypercholesterolemia With Concomitant Type 2 Diabetes, run by Listen Trial Group at 133 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level (time frame: Baseline, and 12 months after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.

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