A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: exenatide (LY2148568)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382239

H8O-JE-GWAV

Details and patient eligibility

About

This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.

Enrollment: 153 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 2 diabetes.
• Have a body weight of >=50 kg.

Exclusion criteria

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
• Are treated with any exogenous insulin within 3 months of screening.
• Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
• Have characteristics contraindicating for concomitant medication, according to product-specific label.
• Have severe allergy or hypersensitivity to any drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

153 participants in 4 patient groups, including a placebo group

Exenatide 5 mcg/exenatide 10 mcg

Experimental group

Treatment:

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Exenatide 5 mcg/exenatide 5 mcg

Experimental group

Treatment:

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Exenatide 2.5 mcg/exenatide 2.5 mcg

Experimental group

Treatment:

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Drug: exenatide (LY2148568)

Placebo/placebo

Placebo Comparator group

Treatment:

Drug: Placebo