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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01452451
First received: October 4, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: HM11260C
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Up to 106 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 up to Day 92 ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: Up to 106 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 72
Study Start Date: December 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
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
Other Name: Placebo
Active Comparator: HM11260C
HM11260C
Drug: 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
Other Name: LAPS-Exendin4

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452451

Locations
United States, Ohio
Ohio, Ohio, United States
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01452451     History of Changes
Other Study ID Numbers: HM-EXC-202
Study First Received: October 4, 2011
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014