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A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02059564
Recruitment Status : Unknown
Verified February 2014 by Hanmi Pharmaceutical Company Limited.
Recruitment status was:  Recruiting
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: HM11260C Drug: Placebo Drug: Victoza Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Cohort A
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
Drug: HM11260C
doses of 6 mg, 16 mg
Other Name: LAPS-Exendin-4

Drug: Placebo
Normal saline solution
Other Name: Normal saline solution

Experimental: Cohort B
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
Drug: HM11260C
doses of 6 mg, 16 mg
Other Name: LAPS-Exendin-4

Drug: Placebo
Normal saline solution
Other Name: Normal saline solution

Experimental: Cohort C
The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg
Drug: Victoza
doses of 1.8 mg
Other Name: Liraglutide




Primary Outcome Measures :
  1. PK profile of acetaminophen [ Time Frame: 13 weeks ]
    Cmax, AUC at 13 weeks


Secondary Outcome Measures :
  1. Glucose metabolism [ Time Frame: 13 weeks ]
    Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks

  2. Safety and tolerability [ Time Frame: 18 weeks ]
    Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059564


Contacts
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Contact: Hanmi Clinical clinical4@hanmi.co.kr

Locations
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United States, California
Hanmi Recruiting
California, California, United States
Contact: Hanmi Clinical       clinical4@hanmi.co.kr   
Principal Investigator: Hanmi Clinical         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Hanmi Clinical California, United States
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02059564    
Other Study ID Numbers: HM-EXC-102
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014
Keywords provided by Hanmi Pharmaceutical Company Limited:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exendin-4
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Obesity Agents