Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01306214

1245.49

2010-019968-37 (EudraCT Number)

Details and patient eligibility

About

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

Enrollment: 566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of T2DM prior to informed consent
2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin
3. Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
4. HbA1c >=7.5% and <=10% at screening

Exclusion criteria

1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
2. Any contraindications to metformin according to the local label
3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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566 participants in 3 patient groups, including a placebo group

BI 10773 low dose

Experimental group

Description:

BI 10773 low dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 10773

Drug: BI 10773

Drug: Placebo

BI 10773 high dose

Experimental group

Description:

BI 10733 high dose once daily

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 10773

Drug: BI 10773

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo tablets matching BI 10773

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo