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Type 2 Diabetes MellitusPhase 3NCT02324569

A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes

A Phase 3 study testing SYR-472 in people with Type 2 Diabetes Mellitus, run by Takeda at 65 sites in Japan.

Completed

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

Official record
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Trial summary

The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
SYR-472
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
65 sitesJapan
Study dates
27 Dec 2014to 28 Dec 2016
Phase
Phase 3
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

  • Participant eligibility is determined according to the following criteria:
  • The participant has a diagnosis of type 2 diabetes mellitus.
  • The participant has a fasting C-peptide level of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
  • The participant has a Haemoglobin A1c (HbA1c) value of 7.5% or higher but less than 10.0% at Week -2 of the screening period.
  • The participant has an HbA1c value difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%* (* rounded to one decimal place) of the HbA1c value at the start of the screening period (Week -6).
  • The participant has been on a fixed diet and/or exercise therapy (if any) from at least 6 weeks prior to the start of the screening period (Week -6).
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  • The participant is being treated with insulin preparations alone (≥8 units/day and ≤40 units/day) ** from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen of the insulin preparation.
  • The participant on any one of the following insulin monotherapies: mixed (rapid-acting or short-acting insulin containing no more than 30% volume), intermediate-acting, or long-acting soluble insulin preparations
  • The participant is deemed appropriate for treatment with a combination of insulin and another antidiabetic drug at the start of the screening period (Week -6) by the investigator or subinvestigator.
  • The participants with controlled and stable blood pressure will not need any change in the dose of antihypertensive drugs (including discontinuation and suspension) or additional antihypertensive drugs during the study period as assessed by the investigator or subinvestigator.
  • The participant is male or female and aged 20 years or older at the time of informed consent.
  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent until one month after the end of the study.
  • In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.

Who cannot join

  • Any participant who meets any of the following criteria will not qualify for entry into the study:
  • The participants has clinical manifestations of hepatic impairment [e.g., Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) ≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of the screening period (Week -6) or at Week -2 of the screening period].
  • The participant has moderate or severe renal impairment or end-stage renal failure [e.g., creatinine clearance (Ccr) <50 mL/min at the start of the screening period (Week -6) or Week -2 of the screening period].
  • The participant has any serious cardiac diseases, cerebrovascular disorders, or serious pancreatic or hematological diseases (e.g., participants who require inpatient treatment or are hospitalized for treatment within 24 weeks prior to the start of the screening period).
  • The participant has, in the judgment of the investigator or subinvestigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at the start of the screening period (Week - 6) or Week -2 of the screening period.
  • The participant has a systolic blood pressure of 180 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher during the screening period.
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  • The participant is on at least two antidiabetic therapies other than one insulin preparation one day before 6 weeks prior to the start of the screening period (Week -6) (43 days prior to the start of the screening period).
  • The participants altered the dose and regimen of their insulin preparation within 6 weeks prior to the start of the screening period or during the screening period.
  • The participant experienced hypoglycemia (participants with a blood glucose level of ≤70 mg/dL or hypoglycemic symptoms) within 6 weeks prior to the start of the screening period or during the screening period (at least twice per week).
  • The participant has a fasting blood glucose level of 240 mg/dL or higher at the start of the screening period (Week -6) or at Week -2 of the screening period.
  • The participant has malignancies.
  • The participant has a history of hypersensitivity or allergies to dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin preparations.
  • The participant has a history of gastrectomy or small intestinal resection.
  • The participant is habitual drinker consuming a daily average of more than 100 mL of alcohol.
  • The participant has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependence.
  • The participant is required to take excluded medications during the study period.
  • The participant has received SYR-472 in a previous clinical study.
  • The participant is deemed to be in a condition contraindicating treatment as specified in the package insert of insulin preparations by the investigator or subinvestigator.
  • The participant received any investigational products (including study drugs in a post-marketing clinical study) within 12 weeks prior to the start of the screening period.
  • The participant is participating in other clinical studies at the time of informed consent.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
  • The participant is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  • The participant is hospitalized during the screening period or deemed as requiring hospitalization during the study period by the investigator or subinvestigator, unless the hospitalization is for short-term evaluations including complete health checkups.
  • The participant is deemed to be ineligible for the study for any other reason by the investigator or subinvestigator.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

Japan65 sites

  • Study site

    Ageo, Saitama

  • Study site

    Ageo

  • Study site

    Aomori

  • Study site

    Chiba

  • Study site

    Chigasaki, Kanagawa

  • Study site

    Chigasaki

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Chiyoda-ku

  • Study site

    Fujisawa, Kanagawa

  • Study site

    Fujisawa

  • Study site

    Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hamamatsu

  • Study site

    Hirakata, Osaka

  • Study site

    Hirakata

  • Study site

    Hirosaki, Aomori

  • Study site

    Hirosaki

  • Study site

    Kagoshima

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kanazawa

  • Study site

    Kashihara, Osaka

  • Study site

    Kashiwara

  • Study site

    Koga, Ibaragi

  • Study site

    Koga

  • Study site

    Koyama, Tochigi

  • Study site

    Koyama

  • Study site

    Kumamoto

  • Study site

    Kurume, Fukuoka

  • Study site

    Kurume

  • Study site

    Kyoto

  • Study site

    Mito, Ibaragi

  • Study site

    Mito

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nagoya

  • Study site

    Naka, Ibaragi

  • Study site

    Naka

  • Study site

    Nerima-ku, Tokyo

  • Study site

    Nerima-ku

  • Study site

    Osaka

  • Study site

    Sangō

  • Study site

    Sangou, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Satsumakawauchi, Kagoshima-ken

  • Study site

    Satsumakawauchi

  • Study site

    Sendai, Miyagi

  • Study site

    Sendai

  • Study site

    Shimada, Shizuoka

  • Study site

    Shimada

  • Study site

    Shimono, Tochigi

  • Study site

    Shimono

  • Study site

    Shimonoseki, Yamaguchi

  • Study site

    Shimonoseki

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shinjuku-ku

  • Study site

    Shizuoka

  • Study site

    Shunann, Yamaguchi

  • Study site

    Suginami-ku, Tokyo

  • Study site

    Suginami-ku

  • Study site

    Suita, Osaka

  • Study site

    Tama, Tokyo

  • Study site

    Tama

  • Study site

    Toyama

  • Study site

    Tsuchiura, Ibaragi

  • Study site

    Tsuchiura

  • Study site

    Ushiku, Ibaragi

Other trials in Japan

About this study

Official title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative Study and a Phase 4, Multicenter, Open-label, Long-term Study to Evaluate the Safety and Efficacy of SYR-472 When Orally Administered at a Dose of 100 mg Once Weekly as an add-on to Insulin Therapy in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Treatment With Insulin Preparations in Addition to Diet and/or Exercise Therapy

The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Read the detailed description

This is a phase 4, multicenter, randomized, double-blind, parallel-group, comparative study using placebo (Treatment Period I) and a phase 4, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg as an add-on to insulin therapy in patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin preparations in addition to diet and/or exercise therapy.

Being tested
SYR-472, Placebo
Keywords
Pharmacological therapy
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.

  • SYR-472Drug

    SYR-472 tablets

  • PlaceboDrug

    Placebo tablets

Study groups in NCT02324569
Study groupRoleWhat they receive
Treatment Group IExperimentalOne tablet of SYR-472 100 mg orally once weekly before breakfast
Receives: Drug: SYR-472
Treatment Group IIExperimentalOne tablet of SYR-472 100 mg orally or one placebo tablet orally once weekly before breakfast
Receives: Drug: SYR-472; Drug: Placebo

What is being measured

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

  1. Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period)

    Measured: End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)

  2. Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II

    Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.

    Measured: Up to Week 12

Secondary outcomes (8)

  1. Change From Baseline in HbA1c

    Reported data was the change from baseline in HbA1c at each time point.

    Measured: Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)

  2. Change From Baseline in Fasting Plasma Glucose

    Reported data was the change from baseline in fasting plasma glucose at each time point.

    Measured: Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)

  3. Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I

    Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point.

    Measured: Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)

  4. Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II

    Here "mmHg" is Millimeter of mercury.

    Measured: Up to Week 12

  5. Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II

    Here "QTcF" is Corrected QT interval by Fridericia formula, and "msec" is millisecond.

    Measured: Up to Week 12

  6. Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II

    Measured: Up to Week 12

  7. Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II

    Measured: Up to Week 53

  8. Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast

    Reported data was the change from baseline in self-monitoring of blood glucose before breakfast.

    Measured: Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)

Timeline

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

  1. First posted24 Dec 2014 (estimated)
  2. Study start27 Dec 2014
  3. Primary completion28 Dec 2016
  4. Study completion28 Dec 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02324569
Sponsor's protocol ID
SYR-472/CCT-101
Other IDs
U1111-1164-8291
Status last verified
Dec 2023
First submitted
19 Dec 2014
Last updated
12 Dec 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYR-472 in people with Type 2 Diabetes Mellitus, run by Takeda at 65 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 14 inclusion and 24 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2019). 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?

Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period) (time frame: End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)). 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 NCT02324569.

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 12 Dec 2023.

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