Phase 2
Completed N=495
BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00749190 ↗Enrolled (actual)
495
Serious AEs
2.2%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in HbA1c After 12 Weeks of Treatment — 0.15; -0.09; -0.23; -0.56 percentage of HbA1c — p=0.0226
Summary
The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c After 12 Weeks of Treatment |
0.15; -0.09; -0.23; -0.56; -0.55; -0.49 | 0.0226 sig |
| SECONDARY Change of FPG From Baseline After 12 Weeks of Treatment |
4.75; -1.70; -15.84; -22.14; -26.83; -27.91 | — |
| SECONDARY Change of HbA1c From Baseline Over Time |
0.02; -0.12; -0.16; -0.32; -0.31; -0.36 | — |
| SECONDARY Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment |
15.5; 23.9; 21.1; 38.0; 37.1; 35.7 | — |
| SECONDARY Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment |
21.1; 31.0; 40.8; 60.6; 60.0; 48.6 | — |
| SECONDARY Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) |
0.43; 0.09; -0.84; -1.77; -0.11; -1.52 | — |
| SECONDARY Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) |
0.23; -0.11; -0.60; -1.04; -0.52; -1.10 | — |
| SECONDARY Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) |
0.30; 0.08; 0.36; 1.55; 6.68; 4.01 | — |
| SECONDARY Change of Body Weight After 12 Weeks of Treatment |
-1.16; -1.55; -2.28; -2.74; -2.56; -2.85 | — |
| SECONDARY Trough Concentrations of Empagliflozin in Plasma |
3.19; 13.1; 27.3; 92.5; 119; 2.93 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
- Stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose.
- HbA1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and HbA1c >7.0% to 10% for patients on metformin only
- HbA1c >7.0% to 10.0% at Visit 2 (Start of Run-in)
- Age >=18 and <80years
- Body Mass Index (BMI) <=40 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial
- Chronic or clinically relevant acute infections
- Current or chronic urogenital tract infection
- History of clinically relevant allergy/hypersensitivity
- Treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (GLP-1) analogues, or insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs within 3 months prior to informed consent
- Treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Alcohol abuse or drug abuse
- Treatment with an investigational drug within 2 months prior to informed consent
- Women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial
Data sourced from ClinicalTrials.gov (NCT00749190). 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.