Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: HM11260C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081118

HM-EXC-204

Details and patient eligibility

About

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).

Enrollment: 209 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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209 participants in 4 patient groups, including a placebo group

HM11260C (8 mg)

Experimental group

Description:

Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks

Treatment:

Drug: HM11260C

HM11260C (12 mg)

Experimental group

Description:

Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks

Treatment:

Drug: HM11260C

HM11260C (16 mg)

Experimental group

Description:

Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks

Treatment:

Drug: HM11260C

Placebo

Placebo Comparator group

Description:

Monthly administration of placebo by subcutaneous injection for 16 weeks

Treatment:

Drug: Placebo