Overview

This trial has been completed.

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 February 2017
Trial size 298 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
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
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

All 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 March 2017.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..