Type 2 Diabetes MellitusPhase 2NCT02647320
12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
A Phase 2 study testing Sitagliptin 100 mg and DS-8500a 25mg in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 58 sites in 2 countries.
Trial summary
The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sitagliptin 100 mg and DS-8500a 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Jan 2016to 31 Jan 2017
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent and adhere to the study visit schedule and treatment
- Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
- Male or female ≥ 18 and ≤ 70 years of age
- Screening fasting C-peptide > 0.5 ng/mL
- Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
- WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) before entering the Lead-in Period
Show all 10Show fewer
- Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit
- On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day
- Screening HbA1c ≥ 7.0% and ≤ 10%
- Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period
Who cannot join
- History of type 1 diabetes and/or history of ketoacidosis
- History of insulin use for > 2 weeks within 2 months prior to the Screening Visit
- Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) > 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of > 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
- Screening hemoglobin <12 g/dL for males and <11 g/dL for females
- Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
- Subjects after bariatric surgery or any gastric bypass
Show all 26Show fewer
- Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )
- Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2.0 x upper limit of normal (ULN), and/or total bilirubin > 1.5 x ULN. If a subject has total bilirubin > 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled
- Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) < 50 mL/min for both males and females
- Screening Creatine kinase (CK) > 3.0 × ULN
- History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
- History of congestive heart failure (CHF)
- Exclusionary concomitant medications:
- Eight weeks prior to screening and throughout the duration of the study:
- Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.
- Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.
- Rosuvastatin > 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)
- Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)
- Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)
- Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year
- Any history of a malignancy other than basal cell carcinoma within the past 5 years
- Pregnancy or breast-feeding, or intent to become pregnant during the study period
- Known (or evidence of) infection with human immunodeficiency virus
- Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest
- Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
- A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States48 sites
Study site
Anaheim, California, 92801
Study site
Atlanta, Georgia, 30331
Study site
Austin, Texas, 78705
Study site
Avon, Indiana, 46123
Study site
Birmingham, Alabama, 35216
Study site
Boise, Idaho, 83704
Study site
Burke, Virginia, 22015
Study site
Charleston, South Carolina, 29407
Study site
Charleston, South Carolina, 29425
Study site
Chino, California, 91710
Study site
Chula Vista, California, 91911
Study site
Colorado Springs, Colorado, 80920
Study site
Columbus, Ohio, 43213
Study site
Council Bluffs, Iowa, 51503
Study site
Dallas, Texas, 75231
Study site
Edina, Minnesota, 55435
Study site
Evansville, Indiana, 47725
Study site
Franklin, Indiana, 46131
Study site
Fresno, California, 93720
Study site
Gold River, California, 95670
Study site
Greenbrae, California, 94904
Study site
Greenfield, Indiana, 46140
Study site
Greer, South Carolina, 29651
Study site
Hallandale, Florida, 33009
Study site
Houston, Texas, 77036
Study site
Lakewood, Colorado, 80227
Study site
Litchfield Park, Arizona, 85340
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33126
Study site
Miami, Florida, 33135
Study site
Mooresville, North Carolina, 28117
Study site
Morgantown, North Carolina, 28655
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Omaha, Nebraska, 68114
Study site
Pembroke Pines, Florida, 33026
Study site
Plano, Texas, 75024
Study site
Salt Lake City, Utah, 84102
Study site
Salt Lake City, Utah, 84121
Study site
San Antonio, Texas, 78228
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92103
Study site
South Jordan, Utah, 84095
Study site
Spartanburg, South Carolina, 29303
Study site
Tempe, Arizona, 85282
Study site
Troy, Michigan, 48098
Study site
Washington, Missouri, 63090
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103
Canada10 sites
Study site
Brampton, Ontario, L6T 0G1
Study site
London, Ontario, N5W 6A2
Study site
Mirabel, Quebec, J7J 2K8
Study site
Montreal, Quebec, H4N 2W2
Study site
Newmarket, Ontario, L3Y 5GB
Study site
Québec, Quebec, G1W 4R4
Study site
Sherbrooke, Quebec, J1H 1Z1
Study site
Toronto, Ontario, M9V 4B4
Study site
Toronto, Ontario, M9W 4L6
Study site
Victoria, British Columbia, V8V 4A1
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin 100 mg, DS-8500a 25mg, Placebo Tablet, Placebo Capsule
- Keywords
- type 2 diabetes mellitus, interventional, double blind, phase 2
- 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.
Sitagliptin 100 mgDrug
Also called Januvia
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
DS-8500a 25mgDrug
Also called Investigational product
DS-8500a 25mg tablet for oral administration
Placebo TabletDrug
Also called Placebo
Placebo matching DS-8500a tablet for oral administration
Placebo CapsuleDrug
Also called Placebo
Placebo matching sitagliptin over-capsule for oral administration
| Study group | Role | What they receive |
|---|---|---|
| DS-8500a 25mg | Experimental | One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose Receives: Drug: DS-8500a 25mg; Drug: Placebo Tablet; Drug: Placebo Capsule |
| DS-8500a 50 mg | Experimental | Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose Receives: Drug: DS-8500a 25mg; Drug: Placebo Tablet; Drug: Placebo Capsule |
| DS-8500a 75 mg | Experimental | Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose Receives: Drug: DS-8500a 25mg; Drug: Placebo Capsule |
| Placebo | Placebo comparator | Three placebo tablets and one placebo capsule in a once-daily oral dose Receives: Drug: Placebo Tablet; Drug: Placebo Capsule |
| Sitagliptin 100 mg | Active comparator | Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose Receives: Drug: Sitagliptin 100 mg; Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Measured: Baseline, Week 12
Secondary outcomes (14)
Change From Baseline in Total Cholesterol (TC) at Week 12
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Measured: Baseline, Week 12
Change From Baseline in LDL-C at Week 12
LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.
Measured: Baseline, Week 12
Change From Baseline in HDL-C at Week 12
HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.
Measured: Baseline, Week 12
Change From Baseline in Non-HDL-C at Week 12
Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).
Measured: Baseline, Week 12
Change From Baseline in Triglycerides at Week 12
Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.
Measured: Baseline, Week 12
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Measured: Baseline, Week 4
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Measured: Baseline, Week 12
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Measured: Baseline, Week 4
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Measured: Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Measured: Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Measured: Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Measured: Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Measured: Baseline, Week 12
Count of Participants With HbA1c Less Than 7.0% at Week 12
HbA1C less than 7% is the success goal for many Type 2 diabetics.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647320
- Sponsor's protocol ID
- DS8500-A-U202
- Status last verified
- May 2018
- First submitted
- 4 Jan 2016
- Last updated
- 25 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
- ClinicalTrials.gov ID
- NCT02647320
- Acronym / sponsor ID
- DS8500-A-U202
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, interventional, double blind, phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 1 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DS-8500a 25mg | Experimental | Drug: DS-8500a 25mg, Drug: Placebo Tablet, Drug: Placebo CapsuleOne DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose |
| DS-8500a 50 mg | Experimental | Drug: DS-8500a 25mg, Drug: Placebo Tablet, Drug: Placebo CapsuleTwo DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose |
| DS-8500a 75 mg | Experimental | Drug: DS-8500a 25mg, Drug: Placebo CapsuleThree DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose |
| Placebo | Placebo comparator | Drug: Placebo Tablet, Drug: Placebo CapsuleThree placebo tablets and one placebo capsule in a once-daily oral dose |
| Sitagliptin 100 mg | Active comparator | Drug: Sitagliptin 100 mg, Drug: Placebo TabletThree placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide written informed consent and adhere to the study visit schedule and treatment
- Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
- Male or female ≥ 18 and ≤ 70 years of age
- Screening fasting C-peptide > 0.5 ng/mL
- Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
Key exclusion criteria (26 listed)
- History of type 1 diabetes and/or history of ketoacidosis
- History of insulin use for > 2 weeks within 2 months prior to the Screening Visit
- Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) > 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of > 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
- Screening hemoglobin <12 g/dL for males and <11 g/dL for females
- Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin 100 mgAlso: JanuviaTwo sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration | Drug | Sitagliptin 100 mg |
| DS-8500a 25mgAlso: Investigational productDS-8500a 25mg tablet for oral administration | Drug | DS-8500a 25mg, DS-8500a 50 mg, DS-8500a 75 mg |
| Placebo TabletAlso: PlaceboPlacebo matching DS-8500a tablet for oral administration | Drug | DS-8500a 25mg, DS-8500a 50 mg, Placebo, Sitagliptin 100 mg |
| Placebo CapsuleAlso: PlaceboPlacebo matching sitagliptin over-capsule for oral administration | Drug | DS-8500a 25mg, DS-8500a 50 mg, DS-8500a 75 mg, Placebo |
Primary outcome
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline, Week 12
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
14 secondary outcomes
Change From Baseline in Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in LDL-C at Week 12
Time frame: Baseline, Week 12
Change From Baseline in HDL-C at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Triglycerides at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
Time frame: Baseline, Week 4
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time frame: Baseline, Week 12
Count of Participants With HbA1c Less Than 7.0% at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin 100 mg and DS-8500a 25mg in people with Type 2 Diabetes Mellitus, run by Daiichi Sankyo at 58 sites in 2 countries.
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 10 inclusion and 26 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 May 2018). 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 From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2019.