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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: HM11260C
* Drug: Placebo
* Drug: Victoza


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>The weekly treatment of the 6 mg HM11260C or placebo will be maintained | Drug: HM11260C<br>* doses of 6 mg, 16 mg<br>* Other names: LAPS-Exendin-4;Drug: Placebo<br>* Normal saline solution<br>* Other names: Normal saline solution;|
| Experimental: Cohort B<br>The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg | Drug: HM11260C<br>* doses of 6 mg, 16 mg<br>* Other names: LAPS-Exendin-4;Drug: Placebo<br>* Normal saline solution<br>* Other names: Normal saline solution;|
| Experimental: Cohort C<br>The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg | Drug: Victoza<br>* doses of 1.8 mg<br>* Other names: Liraglutide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of acetaminophen | Cmax, AUC at 13 weeks | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism | Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks | 13 weeks | 
| Safety and tolerability | Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Exendin-4