The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Lispro Mid Mix; Drug: Lispro; Drug: Lispro Low Mix; Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279201

10455

F3Z-US-IOOV (Other Identifier)

Details and patient eligibility

About

This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.

Enrollment: 2,091 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have type 2 diabetes.
• Must be at least 30 and less than 80 years of age at the time of Visit 1.
• Must be on at least two oral antidiabetes medications for at least 90 days.
• Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion criteria

• Must not have used insulin on a regular basis in the last 12 months.
• Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
• Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
• Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
• Must not be pregnant or intend to get pregnant during course of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,091 participants in 6 patient groups

Insulin glargine

Active Comparator group

Description:

Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.

Treatment:

Drug: Insulin glargine

Lispro Low Mix

Experimental group

Description:

Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.

Treatment:

Drug: Lispro Low Mix

Lispro Mid Mix prior Lispro Low Mix addendum

Experimental group

Description:

Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.

Treatment:

Drug: Lispro Mid Mix

Lispro Low Mix prior Glargine addendum

Experimental group

Description:

Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase

Treatment:

Drug: Lispro Low Mix

Basal bolus prior Lispro Low Mix addendum

Active Comparator group

Description:

Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.

Treatment:

Drug: Insulin glargine

Drug: Lispro

Basal bolus prior Glargine addendum

Active Comparator group

Description:

Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.

Treatment:

Drug: Insulin glargine

Drug: Lispro