Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments sitagliptin 100 mg, ds-8500a 25mg, placebo
Phase phase 2
Sponsor Daiichi Sankyo Inc.
Start date January 2016
End date January 2017
Trial size 260 participants
Trial identifier NCT02647320, DS8500-A-U202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
One DS-8500a 25 mg capsule plus placebo
ds-8500a 25mg
DS-8500a 25mg
placebo
placebo to match both sitagliptin and DS-8500a
(Experimental)
Two DS-8500a 25 mg capsules plus placebo
ds-8500a 25mg
DS-8500a 25mg
placebo
placebo to match both sitagliptin and DS-8500a
(Experimental)
Three DS-8500a 25 mg capsules
ds-8500a 25mg
DS-8500a 25mg
placebo
placebo to match both sitagliptin and DS-8500a
(Placebo Comparator)
placebo capsules
placebo
placebo to match both sitagliptin and DS-8500a
(Active Comparator)
One Sitagliptin 100 mg capsule plus placebo
sitagliptin 100 mg Januvia
Sitagliptin 100 mg
placebo
placebo to match both sitagliptin and DS-8500a

Primary Outcomes

Measure
change from baseline in HbA1c at Week 12
time frame: Day 0 (baseline) to week 12

Secondary Outcomes

Measure
change from baseline in total cholesterol (TC) at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in LDL-C at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in HDL-C at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in non-HDL-C at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in triglycerides at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in AUC0-3h of PG in response to MMTT at Week 4
time frame: Day 0 (baseline) to week 4
change from baseline in AUC0-3h of PG in response to MMTT at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in Cmax of PG in response to MMTT at Week 4
time frame: Day 0 (baseline) to week 4
change from baseline in Cmax at Week 12
time frame: Day 0 (baseline) to week 12
change from baseline in FPG at Week 2
time frame: Day 0 (baseline) to week 2
change from baseline in FPG at Week 4
time frame: Day 0 (baseline) to week 4
change from baseline in FPG at Week 8
time frame: Day 0 (baseline) to week 8
change from baseline in FPG at Week 12
time frame: Day 0 (baseline) to week 12
proportion of subjects with HbA1c < 7.0% at week 12
time frame: Day 0 (baseline) to week 12

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..