Diabetes Mellitus
Conditions
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.
Interventions
DRUGHM11260C
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
DRUGPlacebo
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
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Up to 106 days | 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
| Measure | Time frame | Description |
|---|---|---|
| The pharmacokinetics in repeat-dose | Day 1 up to Day 92 | * 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 | Up to 106 days | 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. |
Countries
United States
Outcome results
None listed