Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
- Registration Number
- NCT02057172
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HM11260C (3 mg) HM11260C Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks HM11260C (0.3 mg) HM11260C Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks HM11260C (1 mg) HM11260C Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks HM11260C (2 mg) HM11260C Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks HM11260C (4 mg) HM11260C Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks Placebo Placebo Weekly administration of placebo by subcutaneous injection for 12 weeks Liraglutide liraglutide Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
- Primary Outcome Measures
Name Time Method Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks Up to 127 days
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose levels (FPG) Up to 127 days Serum lipid profile Up to day 127 Body weight Up to day 127 7-point glucose profile Up to day 127 Other glycaemic control parameters Up to day 127 Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% Up to 127 days
Trial Locations
- Locations (1)
Hanmi pharmaceutical
🇺🇸CA, California, United States