Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM

Dr. Muhammad Abdulghani

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Drug: Pioglitazone plus exenatide; Drug: insulin glargine and insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02887625

NPRP 5-273-3-079

Details and patient eligibility

About

To compare efficacy, safety and durability of combination therapy with pioglitazone plus GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus sulfonylurea

Full description

poorly controlled (HbA1c >7.5%) T2DM patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive:

1. exenatide weekly injection (2 mg/week)
2. glargine insulin plus insulin aspart which will be titrated to maintain HbA1c <7.0%

Enrollment: 410 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T2DM poorly controlled (HbA1c >7.5%) on metformin (>1700 mg/day) plus sulfonylurea

Exclusion criteria

• type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

Combination Therapy

Experimental group

Description:

pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week

Treatment:

Drug: Pioglitazone plus exenatide

Insulin Therapy

Active Comparator group

Description:

insulin glargine (lantus) will be started every morning and the dose will be weekly increase to achieve fasting plasma glucose (FPG) \<110 mg/dl. and Aspart insulin will be started before meals and the dose is adjusted to maintain HbA1c \<7.0% and postprandial plasma glucose (PPG) \<140 mg/dl

Treatment:

Drug: insulin glargine and insulin aspart