Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: placebo

Drug: exenatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765817

H8O-US-GWCO

Details and patient eligibility

About

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Enrollment

261 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have type 2 diabetes.
Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

metformin (stable dose for 6 weeks)
pioglitazone (stable dose for 6 weeks)
a combination of metformin and pioglitazone (stable dose for 6 weeks)
- Have HbA1C between 7.1% and 10.5%, inclusive.
- Have a body mass index (BMI) ≤45 kg/m2.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion criteria

Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
Women who are breastfeeding.
Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
Have had a kidney transplant or are currently on kidney dialysis.
Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
Are currently on a weight-loss program or have been on one within 3 months of entering the study.
Have had a blood transfusion or severe blood loss within 3 months of entering the study.
Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
Have a history of pancreatitis.
Have received treatment with an experimental drug within 30 days of entering the study.
If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.