Type 2 Diabetes
Conditions
Keywords
glycaemic control, HM11260C, placebo, safety, tolerability, type 2 diabetes mellitus, efficacy, T2DM, glycated haemoglobin (HbA1c), glycosylated haemoglobin (HbA1c), Glucagon-Like Peptide-1 (GLP-1) agonists, blood sugar levels, fasting plasma glucose (FPG)
Brief summary
The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).
Interventions
DRUGHM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
DRUGliraglutide
Liraglutide is a GLP-1 agonist.
DRUGPlacebo
Placebo
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 74 Years
Healthy volunteers
No
Inclusion criteria
* Ages eligible for study : 18 years to 74 years * Genders eligible for study : Male and Female * Diagnosed with T2DM * Received diet and exercise therapy with or without metformin monotherapy * HbA1c levels of between ≥ 7.0% and ≤ 10.0% * Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control * Written informed consent must be obtained
Exclusion criteria
* Pregnant or nursing (lactating) women * Diagnosis of type 1 diabetes mellitus * Uncontrolled diabetes defined as a FPG level of \> 240 mg/dL * A significant change in body weight in the 3 months before screening * Any history of GI intolerance * Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC * Known history of chronic pancreatitis * A history of alcohol or drug abuse or drug addiction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks | Up to 127 days |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose levels (FPG) | Up to 127 days |
| 7-point glucose profile | Up to day 127 |
| Other glycaemic control parameters | Up to day 127 |
| Body weight | Up to day 127 |
| Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% | Up to 127 days |
| Serum lipid profile | Up to day 127 |
Other
| Measure | Time frame |
|---|---|
| Assess the safety and tolerability of HM11260C | Up to day 127 |
| Assess the immunogenicity of HM11260C | Up to day 127 |
Countries
United States
Outcome results
None listed