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

NCT01452451 | Completed Phase 2 DMC

• 1 other identifier: HM-EXC-202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 106 days

Secondary Outcomes (2)

• The pharmacokinetics in repeat-dose

  Day 1 up to Day 92

• The pharmacodynamics in repeat-dose

  Up to 106 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

HM11260C

ACTIVE COMPARATOR

HM11260C

Drug: HM11260C

Interventions

HM11260C 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

Also known as: LAPS-Exendin4

HM11260C

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Unknown Facility

Ohio City, Ohio, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 14, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)