Overview

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