NCT01507038

Brief Summary

The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started Dec 2011

Typical duration for phase_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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

3.1 years

First QC Date

January 5, 2012

Last Update Submit

February 16, 2015

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusYH14617ExenatideYuhan

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at week 12

    Baseline, Week 12

Secondary Outcomes (3)

  • Change from baseline in body weight at week 12

    Baseline, Week 12

  • Change from baseline in fasting plasma glucose at week 12

    Baseline, Week 12

  • Change from baseline in 1,5-anhydroglucitol at week 12

    Baseline, Week 12

Study Arms (4)

Group A

EXPERIMENTAL
Drug: YH14617

Group B

EXPERIMENTAL
Drug: YH14617

Group C

EXPERIMENTAL
Drug: YH14617

Group D

PLACEBO COMPARATOR
Drug: Placebo

Interventions

YH14617DRUG

1mg once weekly

Group A
PlaceboDRUG

Once weekly

Group D

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have signed a written informed consent voluntary, prior to the any procedure
  • Volunteers of aged between 20 years to 75 years
  • Have been diagnosed with type 2 diabetes at least 3 months prior to study
  • Have a body mass index (BMI) of \> 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by \> 5% in weight)
  • Have been treated with stable dose regimen of Metformin \> 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
  • Have an HbA1c between 7% and 10% inclusive

You may not qualify if:

  • Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
  • Have acute disease, other untreated disease or diabetic complications that needs additional treatment
  • Have severe renal disorder(serum creatinine concentration \> 1.5 times of normal upper limit) or liver disorder(liver enzyme \> 2 times of normal upper limit)
  • Have blood pressure \> 160/100mmHg
  • Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
  • Have history of critical disease within 1 year prior to the first administration
  • Have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration
  • Have fasting plasma glucose(FPG) \> 250mg/dl or have random glucose level \> 350mg/dl
  • Have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration
  • Have a known allergy or hypersensitivity to drugs
  • Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
  • Participated in any other clinical trials within 30 days prior to the first administration
  • Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuhan

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dong-Seop Choi, MD, PhD.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 10, 2012

Study Start

December 1, 2011

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

KR(1)