Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 74 |
| Updated: | 8/10/2016 |
| Start Date: | February 2014 |
| End Date: | April 2015 |
A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin
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).
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).
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
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