Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo 0.04 mL twice daily; Drug: B - Exenatide 10 mcg twice daily; Drug: Placebo 0.04 mL once daily; Drug: C - Exenatide 10 mcg once daily; Drug: Placebo 0.08 mL once daily; Drug: Exenatide 20 mcg once daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT00085969

2993-120

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

Exclusion criteria

• Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
• Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 6 patient groups, including a placebo group

A1 - Placebo 0.04 mL twice daily

Placebo Comparator group

Treatment:

Drug: Placebo 0.04 mL twice daily

A2 - Placebo 0.04 mL once daily

Placebo Comparator group

Treatment:

Drug: Placebo 0.04 mL once daily

A3 - Placebo 0.08 mL once daily

Placebo Comparator group

Treatment:

Drug: Placebo 0.08 mL once daily

B - Exenatide 10 mcg twice daily

Experimental group

Treatment:

Drug: B - Exenatide 10 mcg twice daily

C - Exenatide 10 mcg once daily

Experimental group

Treatment:

Drug: C - Exenatide 10 mcg once daily

D - Exenatide 20 mcg once daily

Experimental group

Treatment:

Drug: Exenatide 20 mcg once daily