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

Boehringer Ingelheim566 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

566

Conditions

Diabetes Mellitus, Type 2 Obesity

Interventions

PlaceboDRUG

Placebo matching BI 10773 low dose

PlaceboDRUG

Placebo matching BI 10773 low dose

PlaceboDRUG

Placebo matching BI 10773 high dose

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (103)

Outcomes

Primary Outcomes

Change From Baseline in HbA1c After 18 Weeks of Treatment

The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.

Time frame: Baseline and 18 weeks

Secondary Outcomes

Change From Baseline in Insulin Dose After 52 Weeks of Treatment

The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment

Time frame: Baseline and 52 weeks

Change From Baseline in Body Weight After 52 Weeks of Treatment

The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment

Time frame: Baseline and 52 weeks

Change From Baseline in HbA1c After 52 Weeks of Treatment

The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment

Time frame: Baseline and 52 weeks

Data from ClinicalTrials.gov

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1245.49.10005 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1245.49.10011 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

1245.49.10004 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

1245.49.10002 Boehringer Ingelheim Investigational Site

Corona, California, United States

1245.49.10013 Boehringer Ingelheim Investigational Site

El Cajon, California, United States

1245.49.10030 Boehringer Ingelheim Investigational Site

Lomita, California, United States

1245.49.10014 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

1245.49.10019 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

1245.49.10024 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

1245.49.10018 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

...and 93 more locations