Glycaemic Control of Weekly 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: | January 2014 |
| End Date: | December 2014 |
A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes
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).
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).
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
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