A Phase 2 interventional study of Placebo and Placebo in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 139 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-23.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 983 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patients receive Empagliflozin high dose once daily
Drug: Placebo · Drug: Empagliflozin (high dose qd)
Patients receive Empagliflozin high dose split twice daily
Drug: Placebo · Drug: empagliflozin (high dose bid)
Patients receive Empagliflozin low dose once daily
Drug: empagliflozin (low dose qd) · Drug: Placebo
Patients receive Empagliflozin low dose split twice daily
Drug: Placebo · Drug: empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin
Drug: Placebo
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive Empagliflozin low dose once daily
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive placebo matching empagliflozin (low dose qd)
Patients receive placebo matching empagliflozin (low dose bid)
Patients receive placebo matching Empagliflozin (high dose bid)
Patients receive Empagliflozin high dose once daily
Patients receive Empagliflozin high dose split twice daily
Patients receive placebo matching Empagliflozin (high dose qd)
Patients receive Empagliflozin low dose split twice daily
HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Time frame: Baseline and 16 weeks
Fasting Plasma Glucose (FPG) Change From Baseline at Week 16
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
Time frame: Baseline and 16 weeks
| Milestone | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo |
|---|---|---|---|---|---|
| Started | 219 | 218 | 219 | 220 | 107 |
| Completed | 205 | 205 | 202 | 201 | 103 |
| Not completed | 14 | 13 | 17 | 19 | 4 |
| Withdrew: Adverse event | 5 | 5 | 4 | 13 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Non compliant with protocol | 1 | 0 | 3 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 4 | 3 | 0 |
| Withdrew: Patient withdrawal (not due to ae) | 3 | 6 | 4 | 1 | 1 |
| Withdrew: For other reason | 4 | 1 | 2 | 0 | 0 |
Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
| percentage of HbA1c | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo |
|---|---|---|---|---|---|
| HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 | -0.83 ± 0.05 | -0.72 ± 0.05 | -0.66 ± 0.05 | -0.64 ± 0.05 | -0.22 ± 0.07 |
Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication. Means provided are the adjusted means.
| mg/dL | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo |
|---|---|---|---|---|---|
| Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 | -27.7 ± 2.0 | -22.7 ± 2.0 | -21.2 ± 2.0 | -17.6 ± 2.0 | -0.2 ± 2.8 |
Collected over 16 weeks + 1 week follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Empa 12.5mg BID | — | 5/219 (2.3%) | 10/219 (4.6%) |
| Empa 25mg QD | — | 2/218 (0.9%) | 10/218 (4.6%) |
| Empa 5mg BID | — | 7/219 (3.2%) | 8/219 (3.7%) |
| Empa 10mg QD | — | 5/220 (2.3%) | 15/220 (6.8%) |
| Placebo | — | 1/107 (0.9%) | 4/107 (3.7%) |
| Event | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo |
|---|---|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/219 | 0/218 | 0/219 | 0/220 | 1/107 |
| DiverticulitisInfections and infestations | 0/219 | 1/218 | 0/219 | 0/220 | 0/107 |
| Macular degenerationEye disorders | 0/219 | 1/218 | 0/219 | 0/220 | 0/107 |
| PharyngotonsillitisInfections and infestations | 0/219 | 0/218 | 1/219 | 0/220 | 0/107 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/219 | 0/218 | 1/219 | 0/220 | 0/107 |
| Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/219 | 0/218 | 0/219 | 0/220 | 0/107 |
| Ischaemic strokeNervous system disorders | 1/219 | 0/218 | 0/219 | 0/220 | 0/107 |
| Transient ischaemic attackNervous system disorders | 1/219 | 0/218 | 0/219 | 0/220 | 0/107 |
| Hypertensive crisisVascular disorders | 0/219 | 0/218 | 1/219 | 0/220 | 0/107 |
| Pancreatitis acuteGastrointestinal disorders | 0/219 | 0/218 | 1/219 | 1/220 | 0/107 |
| Event | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo |
|---|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 10/219 | 10/218 | 8/219 | 15/220 | 4/107 |
Full Analysis Set: FAS being defined as all patients randomised, treated with at least one dose of study drug, had a baseline Glycosylated Haemoglobin (HbA1c) and at least one on-treatment HbA1c assessment.
| Age, Continuous(years) | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 57.6 ± 9.9 | 58.2 ± 10.2 | 58.8 ± 9.8 | 58.5 ± 10.8 | 57.9 ± 11.2 | 58.2 ± 10.3 |
| Sex: Female, Male(Participants) | Empa 12.5mg BID | Empa 25mg QD | Empa 5mg BID | Empa 10mg QD | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 92 | 100 | 95 | 106 | 52 | 445 |
| Male | 123 | 114 | 120 | 108 | 55 | 520 |
Showing the first 100 of 139 sites across 18 countries.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim