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Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HM11260C

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Is male or female and 18 to 65 years of age, inclusive, at screening
Has a history of T2DM and a stable dose of metformin
Has HbA1c levels at screening between 7% and 10%

Exclusion Criteria:

Is pregnant or lactating
Has type 1 diabetes
Has a significant change in body weight in the 3 months before screening
Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g.
Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
Has any acute illness within 5 days before first study drug administration
Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
Is a heavy tobacco user(more than 10 cigarettes a day)
Is a heavy alcohol user
Has a positive screen for drugs of abuse

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

HM11260C

Arm Description

Placebo

HM11260C

Outcomes

Primary Outcome Measures

Number of subjects with adverse events as a measure of safety and tolerability

Number of subjects with adverse events as a measure of safety and tolerability when given different regimens to subjects in T2DM with metformin monotherapy

Secondary Outcome Measures

The pharmacokinetics in repeat-dose

Before dosing on the first dosing day (Day 1) After the first dose: 8, 24, 48, 72, 96, 120, and 144 hours after dosing Trough samples (ie, immediately before dosing) will be taken prior to dosing on Days 8, 22, 36, 57, 71, and 85 After the last dose (thirteenth dose) at 8, 24, 48, 72, 96, 120, and 144 hours after dosing and 7, 10, 14, 21, 28, and 35 days after dosing to define the elimination period of HM11260C

The pharmacodynamics in repeat-dose

HbA1c, glycosylated albumin, fructosamine, insulin, and fasting glucose: For all cohorts: screening; Day -1; before dosing on Days 29, 57, and 85; and at follow-up.

Full Information

NCT ID

NCT01452451

First Posted

October 4, 2011

Last Updated

August 8, 2016

Sponsor

Hanmi Pharmaceutical Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT01452451

Brief Title

Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Official Title

A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.

6. Conditions and Keywords

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

Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

HM11260C

Arm Type

Active Comparator

Arm Description

HM11260C

Intervention Type

Drug

Intervention Name(s)

HM11260C

Other Intervention Name(s)

LAPS-Exendin4

Intervention Description

1, 2, and 4 mg for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. 8, 12 and 16 mg for 3 monthly subcutaneous injections for cohorts M1, M2 and M3

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. Placebo for 3 monthly subcutaneous injections for for cohorts M1, M2 and M3

Primary Outcome Measure Information:

Title

Number of subjects with adverse events as a measure of safety and tolerability

Description

Number of subjects with adverse events as a measure of safety and tolerability when given different regimens to subjects in T2DM with metformin monotherapy

Time Frame

Up to 106 days

Secondary Outcome Measure Information:

Title

The pharmacokinetics in repeat-dose

Description

Time Frame

Day 1 up to Day 92

Title

The pharmacodynamics in repeat-dose

Description

HbA1c, glycosylated albumin, fructosamine, insulin, and fasting glucose: For all cohorts: screening; Day -1; before dosing on Days 29, 57, and 85; and at follow-up.

Time Frame

Up to 106 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is male or female and 18 to 65 years of age, inclusive, at screening Has a history of T2DM and a stable dose of metformin Has HbA1c levels at screening between 7% and 10% Exclusion Criteria: Is pregnant or lactating Has type 1 diabetes Has a significant change in body weight in the 3 months before screening Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening Has an estimated glomerular filtration rate rate <75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 <estimated glomerular filtration rate <90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio >30 mg/g. Has alanine aminotransferase or aspartate aminotransferase values >2.0 × upper limit of normal or total bilirubin >1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome Has fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) or >250 mg/dL (>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded. Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding Has any acute illness within 5 days before first study drug administration Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis Is a heavy tobacco user(more than 10 cigarettes a day) Is a heavy alcohol user Has a positive screen for drugs of abuse

Facility Information:

City

Ohio

State/Province

Ohio

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

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