Type 2 Diabetes
Conditions
Brief summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin
Interventions
DRUGHM11260C
Test drug
DRUGPlacebo
Placebo drug
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Adults aged 19 years or older * 2\. Diagnosed with type 2 diabetes * 3\. HbA1c level 7.0% ≤ HbA1c ≤ 10.0% * 4\. Stable administration of metformin (≥1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1 * 5\. 20 kg/m2 ≤ BMI ≤ 45 kg/m2 * 6\. Agree to the recommended exercise and diet regimen during this clinical trial
Exclusion criteria
* 1\. Patients with a history of allergy or resistance to the investigational drug or background therapy * 2\. Patients diagnosed with a type of diabetes other than type 2 diabetes * 3\. Patients with uncontrolled severe diabetic complications * 4\. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis. * 5\. Patients with a history of diabetic coma or precoma * 6\. Those with a history of severe hypoglycemia * 7\. Those whose weight change \> 5 kg * 8\. History of gastrointestinal disease or surgery * 9\. History of bariatric surgery * 10\. History of gallbladder disease * 11\. History of a disease that could affect the interpretation of HbA1c * 12\. History of acute or chronic pancreatitis or pancreatectomy * 13\. History (including family history) of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN2). * 14\. Uncontrolled hypertension * 15\. Severe infections or severe trauma * 16\. Malnutrition, starvation, or debility, as determined by the investigator. * 17\. Pituitary or adrenal insufficiency. * 18\. Tissue hypoxia, such as respiratory failure or shock. * 19\. History of alcoholism or drug abuse * 20\. History of malignant tumors * 21\. Heart failure, Ischemic heart disease, Severe cerebrovascular disease, TIA * 22\. Patients with one of the following clinical laboratory test results : Amylase or Lipase \> 3 X ULN / FPG \> 270 mg/dL * 23\. Patients with severe hepatic impairment or one of the following laboratory test results : AST or ALT \> 3 X ULN / Total bilirubin \> 1.5 X ULN * 24\. Patients with moderate or severe renal impairment * 25\. History of Diabetic medications or weight-loss medications * 26\. Those who have participated in another clinical trial and received investigational drugs within 30 days * 27\. Pregnant or lactating women, or women of childbearing potential * 28\. Women of childbearing potential and men who do not consent to the use of the following contraceptive methods * 29\. Considered by investigator as not appropriate to participate in the clinical study with other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c at 36 weeks compared to baseline | baseline, 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at Week 24 | baseline, 24 weeks |
| Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36 | 24, 36 weeks |
| Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36 | 24, 36 weeks |
| Change from baseline in FPG at Weeks 24 and 36 | baseline, 24, 36 weeks |
| Proportion of subjects receiving rescue medication at Weeks 24 and 36 | 24, 36 weeks |
Countries
South Korea
Contacts
CONTACTJee Won Shon
Outcome results
None listed