Phase 3
Completed N=566
Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01306214 ↗Enrolled (actual)
566
Serious AEs
11.4%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in HbA1c After 18 Weeks of Treatment — -0.50; -0.94; -1.02 percentage of HbA1c — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c After 18 Weeks of Treatment |
-0.50; -0.94; -1.02 | <0.0001 sig |
| SECONDARY Change From Baseline in Insulin Dose After 52 Weeks of Treatment |
10.16; 1.33; -1.06 | 0.004 sig |
| SECONDARY Change From Baseline in Body Weight After 52 Weeks of Treatment |
0.44; -1.95; -2.04 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c After 52 Weeks of Treatment |
-0.81; -1.18; -1.27 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of T2DM prior to informed consent
- 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
- Stable metformin therapy: daily dose >=1500 mg/day or maximum tolerated dose
- HbA1c >=7.5% and 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
- Any contraindications to metformin according to the local label
- Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent
Data sourced from ClinicalTrials.gov (NCT01306214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.