A Phase 3 interventional study of BI 10773 and Placebo in Diabetes Mellitus, Type 2 and Renal Insufficiency, sponsored by Boehringer Ingelheim. Completed at 127 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-16.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 741 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency 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:
BI 10773 tablets once daily
Drug: BI 10773 · Drug: Placebo
BI 10773 tablets once daily
Drug: Placebo · Drug: BI 10773
Placebo tablets matching BI 10773
Drug: Placebo
BI 10773 tablets once daily
Placebo tablets identical to BI 10773 low dose
Placebo tablets identical to BI 10773 high dose
BI 10773 tablets once daily
Placebo tablets identical to BI 10773 low dose
Placebo tablets identical to BI 10773 high dose
HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
Time frame: Baseline and 24 weeks
HbA1c Change From Baseline in Patients With Mild Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.
Time frame: Baseline and 24 weeks
HbA1c Change From Baseline in Patients With Moderate Renal Impairment
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.
Time frame: Baseline and 24 weeks
Hypoglycaemic Events
Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values \<= 70 mg/dL (\<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.
Time frame: From first drug administration until 7 days after last trial medication intake, up to 458 days
| Milestone | Placebo | Empa 10mg | Empa 25mg |
|---|---|---|---|
| Started | 321 | 98 | 322 |
| Completed | 278 | 88 | 280 |
| Not completed | 43 | 10 | 42 |
| Withdrew: Not treated | 2 | 0 | 1 |
| Withdrew: Adverse event | 18 | 4 | 21 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Non compliant with protocol | 1 | 1 | 4 |
| Withdrew: Lost to follow-up | 3 | 0 | 3 |
| Withdrew: Patient refusal to continue,not due toae | 10 | 4 | 8 |
| Withdrew: Other reason not defined above | 9 | 1 | 4 |
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
| percentage of HbA1c | Placebo | Empa 25mg |
|---|---|---|
| HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment | 0.05 ± 0.04 | -0.46 ± 0.04 |
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.
| percentage of HbA1c | Placebo | Empa 10mg | Empa 25mg |
|---|---|---|---|
| HbA1c Change From Baseline in Patients With Mild Renal Impairment | 0.06 ± 0.07 | -0.46 ± 0.07 | -0.63 ± 0.07 |
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.
| percentage of HbA1c | Placebo | Empa 25mg |
|---|---|---|
| HbA1c Change From Baseline in Patients With Moderate Renal Impairment | 0.05 ± 0.05 | -0.37 ± 0.05 |
Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values \<= 70 mg/dL (\<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.
| percentage of participants | Placebo | Empa 10mg | Empa 25mg |
|---|---|---|---|
| Hypoglycaemic Events | 27.6 | 26.5 | 27.4 |
Collected over From first drug administration until 7 days after last trial medication intake, up to 458 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 44/319 (13.8%) | 207/319 (64.9%) |
| Empa 10mg | — | 6/98 (6.1%) | 64/98 (65.3%) |
| Empa 25mg | — | 40/321 (12.5%) | 187/321 (58.3%) |
| Event | Placebo | Empa 10mg | Empa 25mg |
|---|---|---|---|
| Acute coronary syndromeCardiac disorders | 0/319 | 1/98 | 0/321 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 0/319 | 1/98 | 0/321 |
| Chest painGeneral disorders | 3/319 | 1/98 | 0/321 |
| Cholecystitis acuteHepatobiliary disorders | 0/319 | 1/98 | 0/321 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/319 | 1/98 | 1/321 |
| Benign prostatic hyperplasiaReproductive system and breast disorders | 0/319 | 1/98 | 0/321 |
| Aortic stenosisVascular disorders | 0/319 | 1/98 | 0/321 |
| Cardiac failureCardiac disorders | 3/319 | 0/98 | 0/321 |
| Renal failure acuteRenal and urinary disorders | 3/319 | 0/98 | 3/321 |
| Urinary tract infectionInfections and infestations | 2/319 | 0/98 | 3/321 |
| Event | Placebo | Empa 10mg | Empa 25mg |
|---|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 92/319 | 27/98 | 89/321 |
| Upper respiratory tract infectionInfections and infestations | 25/319 | 14/98 | 35/321 |
| Urinary tract infectionInfections and infestations | 39/319 | 14/98 | 38/321 |
| HyperglycaemiaMetabolism and nutrition disorders | 41/319 | 4/98 | 23/321 |
| NasopharyngitisInfections and infestations | 29/319 | 6/98 | 27/321 |
| Back painMusculoskeletal and connective tissue disorders | 19/319 | 8/98 | 19/321 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 10/319 | 8/98 | 6/321 |
| CoughRespiratory, thoracic and mediastinal disorders | 25/319 | 2/98 | 11/321 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 21/319 | 7/98 | 13/321 |
| HypertensionVascular disorders | 20/319 | 1/98 | 14/321 |
Baseline characteristics are presented for treated patients only.
| Age, Continuous(years) | Placebo | Empa 10mg | Empa 25mg | Total |
|---|---|---|---|---|
| Mean | 64.1 ± 8.7 | 63.2 ± 8.5 | 63.9 ± 9.0 | 63.9 ± 8.8 |
| Sex: Female, Male(Participants) | Placebo | Empa 10mg | Empa 25mg | Total |
|---|---|---|---|---|
| Female | 138 | 38 | 132 | 308 |
| Male | 181 | 60 | 189 | 430 |
Showing the first 100 of 127 sites across 15 countries.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim