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

Primary Purpose

Diabetes Mellitus

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HM11260C

Placebo

Victoza

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Exendin-4

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

HanmiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

The weekly treatment of the 6 mg HM11260C or placebo will be maintained

The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg

The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Outcomes

Primary Outcome Measures

PK profile of acetaminophen

Cmax, AUC at 13 weeks

Secondary Outcome Measures

Glucose metabolism

Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks

Safety and tolerability

Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks

Full Information

NCT ID

NCT02059564

First Posted

February 5, 2014

Last Updated

February 7, 2014

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT02059564

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2013 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

Keywords

Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Exendin-4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A

Arm Type

Experimental

Arm Description

The weekly treatment of the 6 mg HM11260C or placebo will be maintained

Arm Title

Cohort B

Arm Type

Experimental

Arm Description

The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg

Arm Title

Cohort C

Arm Type

Experimental

Arm Description

The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Intervention Type

Drug

Intervention Name(s)

HM11260C

Other Intervention Name(s)

LAPS-Exendin-4

Intervention Description

doses of 6 mg, 16 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal saline solution

Intervention Description

Normal saline solution

Intervention Type

Drug

Intervention Name(s)

Victoza

Other Intervention Name(s)

Liraglutide

Intervention Description

doses of 1.8 mg

Primary Outcome Measure Information:

Title

PK profile of acetaminophen

Description

Cmax, AUC at 13 weeks

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Glucose metabolism

Description

Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks

Time Frame

13 weeks

Title

Safety and tolerability

Description

Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks

Time Frame

18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanmi Clinical

clinical4@hanmi.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanmi Clinical

Organizational Affiliation

California, United States

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hanmi

City

California

State/Province

California

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanmi Clinical

clinical4@hanmi.co.kr

First Name & Middle Initial & Last Name & Degree

Hanmi Clinical

12. IPD Sharing Statement

Citations:

PubMed Identifier

34172436

Citation

Hompesch M, Kang J, Han O, Trautmann ME, Sorli CH, Ogbaa I, Stewart J, Morrow L. Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002208. doi: 10.1136/bmjdrc-2021-002208.

Results Reference

derived

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

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