12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
NCT ID: NCT02647320
Last Updated: 2019-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
298 participants
INTERVENTIONAL
2016-01-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
Sitagliptin 100 mg
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Interventions
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Sitagliptin 100 mg
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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:
a. 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
18 Years
70 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Litchfield Park, Arizona, United States
Tempe, Arizona, United States
Anaheim, California, United States
Chino, California, United States
Chula Vista, California, United States
Fresno, California, United States
Gold River, California, United States
Greenbrae, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Hallandale, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Avon, Indiana, United States
Evansville, Indiana, United States
Franklin, Indiana, United States
Greenfield, Indiana, United States
Council Bluffs, Iowa, United States
Troy, Michigan, United States
Edina, Minnesota, United States
Washington, Missouri, United States
Omaha, Nebraska, United States
Mooresville, North Carolina, United States
Morgantown, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Medford, Oregon, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Burke, Virginia, United States
Victoria, British Columbia, Canada
Brampton, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Mirabel, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DS8500-A-U202
Identifier Type: -
Identifier Source: org_study_id
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