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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059564
• Other study ID #: HM-EXC-102
• Status: Recruiting
• Phase: Phase 1
• First received: February 5, 2014
• Last updated: February 7, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2014
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Hanmi Clinical
• Email: clinical4[@]hanmi.co.kr
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HM11260C
doses of 6 mg, 16 mg
• Placebo
Normal saline solution
• Victoza
doses of 1.8 mg

Locations

Country	Name	City	State
United States	Hanmi	California	California

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile of acetaminophen	Cmax, AUC at 13 weeks	13 weeks	No
Secondary	Glucose metabolism	Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks	13 weeks	No
Secondary	Safety and tolerability	Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks	18 weeks	No