A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
February 7, 2014 updated by: Hanmi Pharmaceutical Company Limited
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects With Type 2 Diabetes Mellitus
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Primary Objective
- effect of multiple different weekly and monthly doses of HM11260C and liraglutide (Victoza) as active control on gastric emptying
Secondary Objectives
- evaluate the pharmacodynamic (PD) effects of multiple weekly and monthly doses of HM11260C and liraglutide after a Mixed Meal Tolerance Test
- evaluate the islet β-cell function after a graded glucose infusion (GGI) of different doses of HM11260C and liraglutide
- evaluate safety and tolerability of different doses of HM11260C and liraglutide
- evaluate the pharmacokinetic (PK) effect of multiple weekly and monthly doses of HM11260C
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
California, California, United States
- Recruiting
- Hanmi
-
Principal Investigator:
- Hanmi Clinical
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- History of type 2 diabetes
- Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- Use of approved methods of contraception
- Ability to provide written informed consent
Exclusion Criteria:
- Type 1 diabetes
- Significant acute diabetic proliferative retinopathy or severe neuropathy
- Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to randomization
- History of any major surgery within 6 months prior to Screening
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or significantly abnormal kidney function tests at Screening
- History of hepatic disease or significantly abnormal liver function tests
- History of any active infection within 30 days prior to Randomization
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
- Donation or loss of >500 mL of blood or blood product within 56 days of Randomization
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort A
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
|
Normal saline solution
Other Names:
doses of 6 mg, 16 mg
Other Names:
|
|
Experimental: Cohort B
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
|
Normal saline solution
Other Names:
doses of 6 mg, 16 mg
Other Names:
|
|
Experimental: Cohort C
The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg
|
doses of 1.8 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PK profile of acetaminophen
Time Frame: 13 weeks
|
Cmax, AUC at 13 weeks
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose metabolism
Time Frame: 13 weeks
|
Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks
|
13 weeks
|
|
Safety and tolerability
Time Frame: 18 weeks
|
Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hanmi Clinical, California, United States
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
February 5, 2014
First Submitted That Met QC Criteria
February 7, 2014
First Posted (Estimate)
February 11, 2014
Study Record Updates
Last Update Posted (Estimate)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 7, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM-EXC-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.