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

October 4, 2011
February 6, 2014
December 2011
June 2013   (final data collection date for primary outcome measure)
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
Number of subjects with adverse events as a measure of safety and tolerability [ 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
Complete list of historical versions of study NCT01452451 on ClinicalTrials.gov Archive Site
  • 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.
  • The pharmacokinetics in repeat-dose [ 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
    HbA1c, glycosylated albumin, fructosamine, insulin, and fasting glucose: For all cohorts: screening; Day -1; before dosing on Days 29, 57, and 85; Days 106 and 120; and at follow-up.
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus
  • 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
  • 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
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: HM11260C
    HM11260C
    Intervention: Drug: HM11260C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01452451
HM-EXC-202
Yes
Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
Not Provided
Not Provided
Hanmi Pharmaceutical Company Limited
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP