NCT01724814

Brief Summary

Study Design: Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1 healthy

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

First Submitted

Initial submission to the registry

November 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

November 5, 2012

Last Update Submit

November 7, 2017

Conditions

HealthyType 1 Diabetes MellitusType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of treatment emergent adverse events

    one year

Secondary Outcomes (1)

  • Peak Plasma Concentration(Cmax) of HM12460A following a single dose in Parts 1-3

    one year

Study Arms (6)

Cohort S1

EXPERIMENTAL

HM12460A Dose 1 (1.2 nmol/kg) or placebo

Drug: HM12460ADrug: Placebo

Cohort S2

EXPERIMENTAL

HM12460A Dose 2 (2.4 nmol/kg) or Placebo

Drug: HM12460ADrug: Placebo

Cohort S3

EXPERIMENTAL

HM12460A Dose 3 (4.8 nmol/kg) or Placebo

Drug: HM12460ADrug: Placebo

Cohort S4

EXPERIMENTAL

HM12460A Dose 4 (9.6 nmol/kg) or Placebo

Drug: HM12460ADrug: Placebo

Cohort S5

EXPERIMENTAL

HM12460A Dose 5 (14.4 nmol/kg) or Placebo

Drug: HM12460ADrug: Placebo

Cohort S6

EXPERIMENTAL

HM12460A Dose 6 (19.2 nmol/kg) or Placebo

Drug: HM12460ADrug: Placebo

Interventions

HM12460ADRUG

Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A

Also known as: LAPS-Insulin
Cohort S1Cohort S2Cohort S3Cohort S4Cohort S5Cohort S6
PlaceboDRUG

Singe dose SC administration of Placebo

Cohort S1Cohort S2Cohort S3Cohort S4Cohort S5Cohort S6

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • Age ≥18 and ≤70 years
  • Non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
  • Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • Non-smoker, or light smoker, defined as \<15 cigarettes/day and able to abstain from smoking during confinement period.
  • Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
  • Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

You may not qualify if:

  • Previous participation in this trial or other clinical trials within the last 3 months.
  • Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (AST or ALT \>2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
  • History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
  • Clinically significant abnormal ECG at screening, as judged by the Investigator.
  • History of alcohol abuse.
  • Any positive reaction of drugs of abuse.
  • Hepatitis B or C or HIV positive.
  • Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi pharma

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 12, 2012

Study Start

December 20, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

US(1)