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Type 2 Diabetes MellitusJ-DISCOVERNCT02226822

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 106 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

This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
Type of treatment
Pill or oral medicine
How many people
1,869 participants
Where
106 sitesJapan
Study dates
20 Sep 2014to 12 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy

Who may be able to join

  • Written consent obtained
  • Aged > = 20 years
  • Diagnosed with type 2 diabetes mellitus
  • Initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class

Who cannot join

  • Diagnosis of Type 1 Diabetes Mellitus
  • Current pregnancy
  • Current treatment for any cancer
  • Current dialysis treatment or renal transplantation
  • Current treatment with any oral steroids
  • Participation in any randomized control trials
  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).

Trial locations and contacts

106 sites in 1 country.

106 sites in 1 country

Japan106 sites

  • Research Site

    Amagasaki, Hyōgo

  • Research Site

    Anjo, Aichi-ken

  • Research Site

    Anzai, Aichi-ken

  • Research Site

    Asahikawa, Hokkaido

  • Research Site

    Chiba

  • Research Site

    Chigasaki, Kanagawa

  • Research Site

    Edogawa-ku, Tokyo

  • Research Site

    Fukui

  • Research Site

    Fukuoka

  • Research Site

    Fukuyama, Hiroshima

  • Research Site

    Funabashi, Chiba

  • Research Site

    Gifu

  • Research Site

    Hachiōji, Tokyo

  • Research Site

    Hakodate, Hokkaido

  • Research Site

    Hamamatsu, Shizuoka

  • Research Site

    Hiratsuka, Kanagawa

  • Research Site

    Hirosaki, Aomori

  • Research Site

    Hiroshima

  • Research Site

    Hitachi, Ibaraki

  • Research Site

    Hitoyoshi, Kumamoto

  • Research Site

    Iida, Nagano

  • Research Site

    Ikuno-ku, Osaka

  • Research Site

    Imari, Saga-ken

  • Research Site

    Ise, Mie-ken

  • Research Site

    Isehara, Kanagawa

  • Research Site

    Isesaki, Gunma

  • Research Site

    Itoshima, Fukuoka

  • Research Site

    Iwade, Wakayama

  • Research Site

    Iwaki, Fukushima

  • Research Site

    Jōetsu, Niigata

  • Research Site

    Kamakura, Kanagawa

  • Research Site

    Kamikawa, Hokkaido

  • Research Site

    Kanazawa, Ishikawa-ken

  • Research Site

    Kanoya, Kagoshima-ken

  • Research Site

    Kanra-gun, Gunma

  • Research Site

    Karatsu, Saga-ken

  • Research Site

    Kashihara, Osaka

  • Research Site

    Kasukabe, Saitama

  • Research Site

    Kawasaki, Kanagawa

  • Research Site

    Kisarazu, Chiba

  • Research Site

    Kita-ku, Tokyo

  • Research Site

    Kitakatsuragi-gun, Nara

  • Research Site

    Kitakyushu, Fukuoka

  • Research Site

    Kobe, Hyōgo

  • Research Site

    Kochi

  • Research Site

    Kofu, Yamanashi

  • Research Site

    Koga, Ibaraki

  • Research Site

    Koganei, Tokyo

  • Research Site

    Kōka, Shiga

  • Research Site

    Kokubunji, Tokyo

  • Research Site

    Komatsu, Aichi-ken

  • Research Site

    Komatsu, Ishikawa-ken

  • Research Site

    Kouka, Shiga

  • Research Site

    Kumamoto

  • Research Site

    Kurate-gun, Fukuoka

  • Research Site

    Kyoto

  • Research Site

    Maibara, Shiga

  • Research Site

    Matsuyama, Ehime

  • Research Site

    Mitaka, Tokyo

  • Research Site

    Miyazaki

  • Research Site

    Muroran, Hokkaido

  • Research Site

    Nagoya, Aichi-ken

  • Research Site

    Nakagawa, Hokkaido

  • Research Site

    Nakami, Yamagata

  • Research Site

    Nasushiobara, Tochigi

  • Research Site

    Nerima-ku, Tokyo

  • Research Site

    Nichinan, Miyazaki

  • Research Site

    Nishimatuura, Saga-ken

  • Research Site

    Oguri, Fukuoka

  • Research Site

    Ōita

  • Research Site

    Okayama

  • Research Site

    Ono, Fukui

  • Research Site

    Ōnojō, Fukuoka

  • Research Site

    Osaka

  • Research Site

    Otaru, Hokkaido

  • Research Site

    Ōtsu, Shiga

  • Research Site

    Oyama, Tochigi

  • Research Site

    Saga

  • Research Site

    Sakado, Saitama

  • Research Site

    Sapporo, Hokkaido

  • Research Site

    Sendai, Miyagi

  • Research Site

    Sennan-gun, Osaka

  • Research Site

    Shibukawa, Gunma

  • Research Site

    Shimotsuga-gun, Tochigi

  • Research Site

    Shinagawa-ku, Tokyo

  • Research Site

    Shinjuku, Tokyo

  • Research Site

    Shirakawa, Fukushima

  • Research Site

    Shizuoka

  • Research Site

    Takamatsu, Kagawa-ken

  • Research Site

    Takasaki, Gunma

  • Research Site

    Tamana, Kumamoto

  • Research Site

    Tamba, Hyōgo

  • Research Site

    Tateyama, Chiba

  • Research Site

    Tochigi

  • Research Site

    Tokushima

  • Research Site

    Tomigusuku, Okinawa

  • Research Site

    Toyonaka, Osaka

  • Research Site

    Tsu, Mie-ken

  • Research Site

    Ube, Yamaguchi

  • Research Site

    Ueda, Nagano

  • Research Site

    Urazoe, Okinawa

  • Research Site

    Ushiku, Ibaraki

  • Research Site

    Yaizu, Shizuoka

  • Research Site

    Yamagata

  • Research Site

    Yokkaichi, Mie-ken

  • Research Site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: J-DISCOVER: DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.

Read the detailed description

This study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of T2DM who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. The follow-up period is 3 years. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Keywords
Type 2 diabetes mellitus
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

Study groups in NCT02226822
Study groupRoleWhat they receive
Adult patients with documented T2DMAdult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy

What is being measured

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

  1. Classes of diabetic medications at baseline and changes up to 3 years

    Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.

    Measured: At 6, 12, 24, 36 month from enrollment

Secondary outcomes (14)

  1. Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals

    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in HbA1c from baseline, achievement rate of HbA1c and blood glucose target goals

    Measured: At 6, 12, 24, 36 month from enrollment

  2. Blood glucose level change from baseline

    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood glucose level (FPG or CPG or PPG) from baseline.

    Measured: At 6, 12, 24, 36 month from enrollment

  3. Body weight change from baseline

    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight.

    Measured: At 6, 12, 24, 36 month from enrollment

  4. Blood pressure change from baseline

    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline.

    Measured: At 6, 12, 24, 36 month from enrollment

  5. Lipid profile changes from baseline

    Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile

    Measured: At 6, 12, 24, 36 month from enrollment

  6. Incidence of microvascular complications

    Overall and by second line anti-diabetic medication class, disease progression in terms of microvascular complications: incidence of chronic nephropathy, dialysis, diabetic retinopathy, retinal photocoagulation, amputation of lower extremity, diabetic foot, peripheral nerve disorders, autonomic nervous system disorders and erectile dysfunction.

    Measured: At 6, 12, 24, 36 month from enrollment

  7. Hypoglycemia events

    Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations

    Measured: At 6, 12, 24, 36 month from enrollment

  8. Patient reported Quality of Life, diet, and physical activity level

    Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level

    Measured: At 6, 12, 24, 36 month from enrollment

  9. Initiation of insulin therapy, Proportion of patients using insulin

    Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin)

    Measured: At 6, 12, 24, 36 month from enrollment

  10. Switching of anti-diabetic medications or dose change

    Switching of anti-diabetic medications or dose change

    Measured: At 6, 12, 24, 36 month from enrollment

  11. Initiation of third line or above add-on anti-diabetic medications

    Initiation of third line or above add-on anti-diabetic medication (e.g., reporting proportion of patients receiving 2nd, 3rd, 4th or greater anti-diabetic therapies at each follow-up visit)

    Measured: At 6, 12, 24, 36 month from enrollment

  12. Incidence of macrovascular complications

    Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke).

    Measured: At 6, 12, 24, 36 month from enrollment

  13. Risk factors

    Risk factors (patient characteristics at baseline: e.g. age, gender, duration of diabetes, presence of co-morbidities) associated with poorer clinical outcomes during follow-up

    Measured: At 6, 12, 24, 36 month after enrollment

  14. Treatment choice

    Determinants of treatment choice

    Measured: At baseline

Timeline

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

  1. First posted27 Aug 2014 (estimated)
  2. Study start20 Sep 2014
  3. Primary completion12 Feb 2019
  4. Study completion12 Feb 2019

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,869 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02226822
Sponsor's protocol ID
D1692R00001
Acronym
J-DISCOVER
Status last verified
Feb 2020
First submitted
26 Aug 2014
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Al Rubeaan K, Banah F, Alruwaily FG, Sheshah E, Alnaqeb D, AlQahtani AM, Ewais D, Al Juhani N, Hassan AH, Youssef AM. Metabolic control and incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy: an analysis of the Saudi Arabia data from the DISCOVER Observational Study programme. BMJ Open. 2023 Aug 30;13(8):e063586. doi: 10.1136/bmjopen-2022-063586.

    PubMed 37648382

  • Mita T, Katakami N, Takahara M, Kawashima M, Wada F, Akiyama H, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H. Changes in Treatment Satisfaction Over 3 Years in Patients With Type 2 Diabetes After Initiating Second-line Treatment. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2424-2432. doi: 10.1210/clinem/dgac420.

    PubMed 35857060

  • Hejjaji V, Gorgojo-Martinez JJ, Tang F, Garnelo JB, Cooper A, Medina J, Mutiozabal MS, Khunti K, Nicolucci A, Shestakova MV, Ji L, Gomes MB, Watada H, Vora J, Malik AO, Kosiborod M, Arnold SV. Factors associated with weight loss in people with overweight or obesity living with type 2 diabetes mellitus: Insights from the global DISCOVER study. Diabetes Obes Metab. 2022 Sep;24(9):1734-1740. doi: 10.1111/dom.14745. Epub 2022 May 25.

    PubMed 35546275

  • Takahara M, Mita T, Katakami N, Wada F, Morita N, Kidani Y, Yajima T, Shimomura I, Watada H; J-DISCOVER study group. Three-Year Glycaemic Control and Management in Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: A Prospective Observational Study, J-DISCOVER. Diabetes Ther. 2022 Feb;13(2):251-264. doi: 10.1007/s13300-021-01192-x. Epub 2021 Dec 28.

    PubMed 34962628

  • Khunti K, Gomes MB, Kosiborod M, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Tang F, Ji L; DISCOVER Scientific Committee and all DISCOVER investigators. Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme. BMJ Open. 2020 Aug 30;10(8):e034613. doi: 10.1136/bmjopen-2019-034613.

    PubMed 32868349

  • Katakami N, Mita T, Takahara M, Yajima T, Wada F, Kawashima M, Shimomura I, Watada H; J-DISCOVER Study Group. Baseline Characteristics of Patients with Type 2 Diabetes Initiating Second-Line Treatment in Japan: Findings from the J-DISCOVER Study. Diabetes Ther. 2020 Jul;11(7):1563-1578. doi: 10.1007/s13300-020-00846-6. Epub 2020 Jun 5.

    PubMed 32504219

  • Khunti K, Chen H, Cid-Ruzafa J, Fenici P, Gomes MB, Hammar N, Ji L, Kosiborod M, Pocock S, Shestakova MV, Shimomura I, Tang F, Watada H, Nicolucci A; DISCOVER investigators. Glycaemic control in patients with type 2 diabetes initiating second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2020 Jan;22(1):66-78. doi: 10.1111/dom.13866. Epub 2019 Oct 1.

    PubMed 31468637

  • Nicolucci A, Charbonnel B, Gomes MB, Khunti K, Kosiborod M, Shestakova MV, Shimomura I, Watada H, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Pocock S. Treatment patterns and associated factors in 14 668 people with type 2 diabetes initiating a second-line therapy: Results from the global DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2474-2485. doi: 10.1111/dom.13830. Epub 2019 Aug 5.

    PubMed 31297947

  • Khunti K, Ji L, Medina J, Surmont F, Kosiborod M. Type 2 diabetes treatment and outcomes worldwide: A short review of the DISCOVER study programme. Diabetes Obes Metab. 2019 Nov;21(11):2349-2353. doi: 10.1111/dom.13817. Epub 2019 Jul 14.

    PubMed 31215715

  • Kosiborod M, Gomes MB, Nicolucci A, Pocock S, Rathmann W, Shestakova MV, Watada H, Shimomura I, Chen H, Cid-Ruzafa J, Fenici P, Hammar N, Surmont F, Tang F, Khunti K; DISCOVER investigators. Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program). Cardiovasc Diabetol. 2018 Nov 28;17(1):150. doi: 10.1186/s12933-018-0787-8.

    PubMed 30486889

  • Katakami N, Mita T, Takahara M, Hashigami K, Kawashima M, Shimomura I, Watada H; J-DISCOVER study group. Rationale and Design for the J-DISCOVER Study: DISCOVERing the Treatment Reality of Type 2 Diabetes in a Real-World Setting in Japan-A Protocol. Diabetes Ther. 2018 Feb;9(1):165-175. doi: 10.1007/s13300-017-0351-7. Epub 2017 Dec 19.

    PubMed 29260460

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 106 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 4 inclusion and 7 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Classes of diabetic medications at baseline and changes up to 3 years (time frame: At 6, 12, 24, 36 month from enrollment). 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 NCT02226822, which also lists 11 linked publications.

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 7 Feb 2020.

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