A Phase 3 interventional study of Placebo and Placebo in Diabetes Mellitus, Type 2 and Obesity, sponsored by Boehringer Ingelheim. Completed at 103 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-17.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 566 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:
BI 10773 low dose once daily
Drug: Placebo · Drug: BI 10773
BI 10733 high dose once daily
Drug: Placebo · Drug: BI 10773
Placebo tablets matching BI 10773
Drug: Placebo
Placebo matching BI 10773 low dose
Placebo matching BI 10773 low dose
Placebo matching BI 10773 high dose
Placebo matching BI 10773 high dose
BI 10773 low dose once daily
BI 10773 high dose once daily
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
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
| Milestone | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Started | 189 | 187 | 190 |
| Completed | 161 | 159 | 168 |
| Not completed | 28 | 28 | 22 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 5 | 4 |
| Withdrew: Withdrawal by subject | 24 | 22 | 16 |
| Withdrew: Not treated | 1 | 1 | 1 |
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
| percentage of HbA1c | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Change From Baseline in HbA1c After 18 Weeks of Treatment | -0.50 ± 0.05 | -0.94 ± 0.05 | -1.02 ± 0.05 |
The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment
| IU/day | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Change From Baseline in Insulin Dose After 52 Weeks of Treatment | 10.16 ± 2.16 | 1.33 ± 2.13 | -1.06 ± 2.14 |
The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment
| kg | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Change From Baseline in Body Weight After 52 Weeks of Treatment | 0.44 ± 0.36 | -1.95 ± 0.36 | -2.04 ± 0.36 |
The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment
| percentage of HbA1c | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| Change From Baseline in HbA1c After 52 Weeks of Treatment | -0.81 ± 0.08 | -1.18 ± 0.08 | -1.27 ± 0.08 |
Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 22/188 (11.7%) | 146/188 (77.7%) |
| Empagliflozin 10 mg | — | 20/186 (10.8%) | 135/186 (72.6%) |
| Empagliflozin 25 mg | — | 22/189 (11.6%) | 140/189 (74.1%) |
| Event | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| PneumoniaInfections and infestations | 1/188 | 3/186 | 1/189 |
| VertigoEar and labyrinth disorders | 0/188 | 2/186 | 1/189 |
| Abdominal painGastrointestinal disorders | 0/188 | 2/186 | 0/189 |
| Coronary artery diseaseCardiac disorders | 2/188 | 0/186 | 1/189 |
| Anal abscessInfections and infestations | 0/188 | 1/186 | 0/189 |
| Gastrointestinal infectionInfections and infestations | 0/188 | 1/186 | 0/189 |
| SepsisInfections and infestations | 0/188 | 1/186 | 0/189 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/188 | 1/186 | 0/189 |
| Pancreatic carcinoma metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/188 | 1/186 | 0/189 |
| SarcoidosisImmune system disorders | 0/188 | 1/186 | 0/189 |
| Event | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg |
|---|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 111/188 | 97/186 | 110/189 |
| NasopharyngitisInfections and infestations | 40/188 | 34/186 | 27/189 |
| Urinary tract infectionInfections and infestations | 23/188 | 24/186 | 24/189 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 10/188 | 18/186 | 11/189 |
| DiarrhoeaGastrointestinal disorders | 17/188 | 12/186 | 17/189 |
| Back painMusculoskeletal and connective tissue disorders | 14/188 | 12/186 | 15/189 |
| HyperglycaemiaMetabolism and nutrition disorders | 14/188 | 6/186 | 7/189 |
| InfluenzaInfections and infestations | 12/188 | 7/186 | 14/189 |
| DizzinessNervous system disorders | 2/188 | 5/186 | 13/189 |
| BronchitisInfections and infestations | 12/188 | 10/186 | 8/189 |
Full Analysis Set (FAS): FAS included all randomised and treated patients who had a baseline HbA1c value.
| Age, Continuous(years) | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | Total |
|---|---|---|---|---|
| Mean | 55.3 ± 10.1 | 56.7 ± 8.7 | 58.0 ± 9.4 | 56.7 ± 9.5 |
| Sex: Female, Male(Participants) | Placebo | Empagliflozin 10 mg | Empagliflozin 25 mg | Total |
|---|---|---|---|---|
| Female | 113 | 89 | 105 | 307 |
| Male | 75 | 97 | 84 | 256 |
Showing the first 100 of 103 sites across 14 countries.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim