NCT01956305

Brief Summary

DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple doses of DS-7309 in subjects with T2DM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

September 30, 2013

Last Update Submit

November 20, 2014

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • safety and tolerability of DS-7309

    number, type and severity of adverse events

    23 days, Day -7 through Day 16

  • determine the pharmacokinetics of DS-7309 after repeated doses

    Cmax, Tmax, area under the concentration curve (AUC)

    23 days, Day-7 through Day 16

  • determine glycemic response

    glycemic response will be assessed by blood sampling for plasma glucose after a meal tolerance test and from 24h weighted mean glucose on Day -1 and Day 12

    23 days, Day -7 through Day 16

Secondary Outcomes (6)

  • To assess the effects of repeated doses of DS-7309 on plasma insulin levels in T2DM subjects

    23 days, Day -7 through Day 16

  • To assess the effects of repeated doses of DS-7309 on blood pressure

    23 days, Day -7 through Day 16

  • To assess the effects of repeated doses of DS-7309 on lipid profile

    23 days, Day -7 through Day 16

  • To assess the effects of repeated doses of DS-7309 on plasma lactate levels

    23 days; Day -7 through Day 16

  • To assess the effects of repeated doses of DS-7309 on C-peptide levels in T2DM subjects

    23 days, Day -7 through Day 16

  • +1 more secondary outcomes

Study Arms (7)

Cohort A 10mg DS-7309

EXPERIMENTAL

DS-7309 10 mg twice daily

Drug: DS-7309

Cohort B 20mg DS-7309

EXPERIMENTAL

DS-7309 20 mg twice daily

Drug: DS-7309

Cohort C DS-7309 40 mg

EXPERIMENTAL

DS-7309 40 mg twice daily

Drug: DS-7309

Cohort D DS-7309 75 mg

EXPERIMENTAL

DS-7309 75 mg twice daily

Drug: DS-7309

Cohort E DS-7309 150 mg

EXPERIMENTAL

DS-7309 150 mg twice daily

Drug: DS-7309

Cohort F DS-7309 150 mg with escalating metformin doses

EXPERIMENTAL

DS-7309 150 mg twice daily with escalating metformin doses

Drug: DS-7309Drug: Metformin

Placebo

PLACEBO COMPARATOR

placebo to match DS-7309

Drug: placebo

Interventions

DS-7309DRUG

DS-7309 powder in bottle

Cohort A 10mg DS-7309Cohort B 20mg DS-7309Cohort C DS-7309 40 mgCohort D DS-7309 75 mgCohort E DS-7309 150 mgCohort F DS-7309 150 mg with escalating metformin doses
placeboDRUG

placebo to match DS-7309 powder in bottle

Placebo
MetforminDRUG

Metformin 500mg tablet for Cohort F

Cohort F DS-7309 150 mg with escalating metformin doses

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female volunteers aged 18 to 65 years, inclusive.
  • Male subjects have to agree to contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another form of contraception
  • Women must be of non-childbearing potential
  • Diagnosed with T2DM for at least 3 months prior to first dose.
  • Subjects must be either:
  • On monotherapy with either metformin or a DPP-IV inhibitor alone with a HbA1c between 6.5% to 9.5%, inclusive, and willing to discontinue current metformin or DPP-IV inhibitor treatment for at least 2 weeks prior to check in and until discharge from the clinic (for Cohorts A to E). OR Treatment naive from any anti-diabetes mellitus drugs for at least 3 months prior to Screening with an HbA1c between 7% to 10%, inclusive.
  • Fasting plasma glucose ≥100 mg/dL and ≤250 mg/dL at Screening.
  • Fasting plasma glucose ≥120 mg/dL and ≤250 mg/dL on Day -6.
  • All women must have a negative serum pregnancy test at Screening and within 2 days before dosing.
  • A BMI of 19 to 36 kg/m2 inclusive; or, if outside the range, not clinically significant and agreed upon by DSPD or the CRO and the Investigator.
  • Good health as determined by the absence of clinically significant deviations from normal, based on medical history, physical examination, laboratory reports, and triplicate 12-lead ECG (except for findings associated with T2DM), as deemed by the Investigator, prior to enrollment.
  • Has given written informed consent prior to participating in the study.
  • Able to understand and willing to comply with all study requirements, and willing to allow the collection of all blood and urine specimens.
  • Negative urine test for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, phencyclidine), cotinine, and alcohol at Screening.
  • Negative result for HIV antibody hepatitis B surface antigen, and hepatitis C antibody at Screening.
  • +2 more criteria

You may not qualify if:

  • History of type 1 diabetes and/or history of diabetic ketoacidosis.
  • History or clinical and laboratory evidence of significant complications of T2DM, including proliferative retinopathy, macroalbuminuria, peripheral neuropathy, ischemic heart disease, stroke, and peripheral vascular disease.
  • Screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator. Liver function tests (AST, ALT, total bilirubin) and lactate dehydrogenase must be at or below 1.5 times ULN. If a subject has a non-clinically significant high abnormal reading for 1 or more of the liver function test results that are at or below 1.5 times ULN on the repeat test, the subject may be enrolled provided the results from the laboratory tests performed on the day after check-in are also at or below 1.5 times ULN.
  • Estimated glomerular filtration rate (eGFR) \<80 mL/min.
  • Any history of drug abuse.
  • History of alcohol addiction during the 2 years prior to Screening.
  • History of significant allergic response to any drug except penicillin.
  • History or current evidence, as determined by the Investigator, of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements.
  • History or current evidence of clinically significant cardiac, hepatic, renal, urinary, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by the Investigator.
  • Subjects with a history of congenital long QT syndrome, a history of surviving a near-drowning episode, or a history of unexplained syncope or loss of consciousness.
  • Subjects with QTcF interval duration \> 450 msec obtained as an average from the ECG machine readings on the triplicate ECG taken at Screening.
  • Subjects with abnormal ECG waveform morphology on any of the ECGs from the screening triplicate that would preclude accurate manual measurement of the QT interval duration.
  • Hemoglobin \< 12.0 g/dL at Screening.
  • Need for any concomitant medication except for those specified Consumption of foods or beverages containing alcohol from 24 hours before check-in through discharge from the clinic.
  • Blood donation of 500 mL or more or significant blood loss within the 56 days before check-in.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations

US(1)