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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: liraglutide; Drug: Placebo; Drug: HM11260C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02057172

HM-EXC-203

Details and patient eligibility

About

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).

Enrollment: 254 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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254 participants in 7 patient groups, including a placebo group

HM11260C (0.3 mg)

Experimental group

Description:

Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks

Treatment:

Drug: HM11260C

HM11260C (1 mg)

Experimental group

Description:

Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks

Treatment:

Drug: HM11260C

HM11260C (2 mg)

Experimental group

Description:

Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks

Treatment:

Drug: HM11260C

HM11260C (3 mg)

Experimental group

Description:

Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks

Treatment:

Drug: HM11260C

HM11260C (4 mg)

Experimental group

Description:

Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks

Treatment:

Drug: HM11260C

Placebo

Placebo Comparator group

Description:

Weekly administration of placebo by subcutaneous injection for 12 weeks

Treatment:

Drug: Placebo

Liraglutide

Active Comparator group

Description:

Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.

Treatment:

Drug: liraglutide