Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
- Registration Number
- NCT02081118
- 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 month 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
- 209
Inclusion Criteria
- Ages eligible for study : 18 years to 74 years
- Genders eligible for study : Male and Female
- Diagnosed with T2DM
- Taking a stable dose of 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 at screening
- 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 acute or 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 Placebo Placebo Monthly administration of placebo by subcutaneous injection for 16 weeks HM11260C (12 mg) HM11260C Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks HM11260C (8 mg) HM11260C Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks HM11260C (16 mg) HM11260C Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks
- Primary Outcome Measures
Name Time Method Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks Up to day 155
- Secondary Outcome Measures
Name Time Method 7-point glucose profile Up to day 155 Glycated albumin Up to day 155 Body weight Up to day 155 Fasting insulin Up to day 155 C-peptide Up to day 155 Glucagon Up to day 155 Serum lipid profile Up to day 155 Fasting plasma glucose levels (FPG) Up to day 155
Trial Locations
- Locations (1)
Hanmi pharmaceutical
🇺🇸Miami, Florida, United States