12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

NCT02647320 | Completed Phase 2 Results

• 1 other identifier: DS8500-A-U202
• Study Type: interventional
• Target: 298
• Locations: 2 countries
• Sites: 58

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; interventional; double blind; phase 2

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Secondary Outcomes (14)

• Change From Baseline in Total Cholesterol (TC) at Week 12

  Baseline, Week 12

• Change From Baseline in LDL-C at Week 12

  Baseline, Week 12

• Change From Baseline in HDL-C at Week 12

  Baseline, Week 12

• Change From Baseline in Non-HDL-C at Week 12

  Baseline, Week 12

• Change From Baseline in Triglycerides at Week 12

  Baseline, Week 12

Study Arms (5)

DS-8500a 25mg

EXPERIMENTAL

One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose

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

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

Drug: DS-8500a 25mg; Drug: Placebo Capsule

Placebo

PLACEBO COMPARATOR

Three placebo tablets and one placebo capsule in a once-daily oral dose

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

Drug: Sitagliptin 100 mg; Drug: Placebo Tablet

Interventions

Sitagliptin 100 mg DRUG

Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration

Also known as: Januvia

Sitagliptin 100 mg

DS-8500a 25mg DRUG

DS-8500a 25mg tablet for oral administration

Also known as: Investigational product

DS-8500a 25mg; DS-8500a 50 mg; DS-8500a 75 mg

Placebo Tablet DRUG

Placebo matching DS-8500a tablet for oral administration

Also known as: Placebo

DS-8500a 25mg; DS-8500a 50 mg; Placebo; Sitagliptin 100 mg

Placebo Capsule DRUG

Placebo matching sitagliptin over-capsule for oral administration

Also known as: Placebo

DS-8500a 25mg; DS-8500a 50 mg; DS-8500a 75 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (58)

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Birmingham, Alabama, 35216, United States

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Litchfield Park, Arizona, 85340, United States

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Tempe, Arizona, 85282, United States

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Anaheim, California, 92801, United States

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Chino, California, 91710, United States

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Chula Vista, California, 91911, United States

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Fresno, California, 93720, United States

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Gold River, California, 95670, United States

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Greenbrae, California, 94904, United States

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San Diego, California, 92103, United States

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Colorado Springs, Colorado, 80920, United States

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Lakewood, Colorado, 80227, United States

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Hallandale, Florida, 33009, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Pembroke Pines, Florida, 33026, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30331, United States

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Boise, Idaho, 83704, United States

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Avon, Indiana, 46123, United States

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Evansville, Indiana, 47725, United States

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Franklin, Indiana, 46131, United States

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Greenfield, Indiana, 46140, United States

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Council Bluffs, Iowa, 51503, United States

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Troy, Michigan, 48098, United States

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Edina, Minnesota, 55435, United States

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Washington, Missouri, 63090, United States

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Omaha, Nebraska, 68114, United States

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Mooresville, North Carolina, 28117, United States

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Morgantown, North Carolina, 28655, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43213, United States

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Medford, Oregon, 97504, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29425, United States

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Greer, South Carolina, 29651, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29303, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77036, United States

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Plano, Texas, 75024, United States

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San Antonio, Texas, 78228, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84121, United States

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South Jordan, Utah, 84095, United States

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Burke, Virginia, 22015, United States

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Victoria, British Columbia, V8V 4A1, Canada

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Brampton, Ontario, L6T 0G1, Canada

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London, Ontario, N5W 6A2, Canada

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Newmarket, Ontario, L3Y 5GB, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Montreal, Quebec, H4N 2W2, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; firuglipel

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Accidental fire at one site changed the baseline number of participants for the modified intent to treat (mITT) set. Because of this, baseline data were included in the outcome measures, rather than in the baseline module.

Results Point of Contact

• Title: Daiichi Sankyo Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

dsclinicaltrial@daiichisankyo.co.jp

+81-3-6225-1111(M-F 9-5 JST)

Study Officials

• Clinical Study Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: February 25, 2019
• Results First Posted: May 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

CA (10); US (48)