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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Exenatide

Criteria

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