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

NCT ID: NCT01452451

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

HM11260C

HM11260C

Group Type: ACTIVE_COMPARATOR

HM11260C

Intervention Type: DRUG

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

Interventions

HM11260C

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

Placebo

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

Intervention Type: DRUG

Other Intervention Names

LAPS-Exendin4

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio City, Ohio, United States

Countries

United States

Other Identifiers

HM-EXC-202

Identifier Type: -

Identifier Source: org_study_id