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

NCT00960661 · Completed

Last updated 2026-05-28

This clinical trial compares two different insulin treatment approaches in adults with type 2 diabetes to see how they affect blood sugar control over 30 weeks.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 1,036 people

Who can join Ages 18+ · all sexes

Timeline Started 2009-09 · est. completion 2012-08

Where 95 sites · Argentina, Belgium, Estonia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, United Kingdom

What this study is testing ClinicalTrials.gov NCT00960661 ↗

Description as written by the study sponsor.

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.

Treatments tested

exenatide also known as Byetta Drug

subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
insulin lispro also known as Humalog Drug

titrated based on pre-meal glucose level; three times a day
Metformin Drug
Insulin/ Glargine Drug

Main thing measured	Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
Sponsor	AstraZeneca
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00960661 ↗