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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Insulin/ Glargine; Drug: exenatide; Drug: insulin lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960661

H8O-EW-GWDM

Details and patient eligibility

About

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.

Enrollment: 1,036 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,036 participants in 2 patient groups

Exenatide (BET)

Experimental group

Description:

Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)

Treatment:

Drug: exenatide

Drug: Metformin

Drug: Insulin/ Glargine

Insulin Lispro (BBT)

Active Comparator group

Description:

Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Treatment:

Drug: insulin lispro

Drug: Metformin

Drug: Insulin/ Glargine