A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | September 2009 |
| End Date: | August 2013 |
| Contact: | Lilly Clinical Trials Support Center |
| Phone: | 1-877-CTLILLY (1-877-285-4559) |
A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a
day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine
(once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects
with Type 2 Diabetes Mellitus who have inadequate glycemic control.
Inclusion Criteria:
- Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3
months prior to study start.
- Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination
with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3
months prior to study start:
- Metformin or immediate-release metformin or extended-release metformin alone at
a maximum tolerated and stable dose with no less than 500 mg/day for at least 6
weeks prior to study start; or
- Metformin or immediate-release metformin or extended-release metformin at a
maximum tolerated and stable dose with no less than 500 mg/day for at least 6
weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior
to study start.
- Have an HbA1C > 7.0% and ≤ 10.0%.
- Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.
Exclusion Criteria:
- Are currently taking OAM that is not described above and not allowed with concurrent
use of insulin per local product label.
- Have taken more than 1 week within 1 month prior to the study start any
glucose-lowering medications not included above either alone or in combination
formulations, or have used a drug for weight loss (for example, prescription drugs
such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar
over-the-counter medications).
- Have taken any insulin other than Glargine within the 3 months prior to study start
for more than 1 week.
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
(excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to
the study start.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an off-label use of an investigational drug or device (other than the
study drug/device used in this study), or concurrently enrolled in any other type of
medical research judged not to be scientifically or medically compatible with this
study.
- Have previously completed or been withdrawn from this study after enrollment.
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