NCT01368081

A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Completed Phase 3 Results posted Last updated 16 May 2014

What this trial tests

Phase 3 trial testing Metformin in Diabetes Mellitus, Type 2 in 1,162 participants. Completed in 1 April 2013.

Timeline

1 May 2011

Primary endpoint
1 April 2013

1 April 2013

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,162
Start date	1 May 2011
Primary completion	1 April 2013
Estimated completion	1 April 2013
Sites	87 locations across Japan

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• BI 10773 — full drug profile →
• Placebo (low dose)
• BI 10773 — full drug profile →
• Placebo (high dose)

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

20 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients With Drug Related Adverse Events
  Time frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days
  Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days

Sponsor's own description

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Update on developments with SGLT2 inhibitors in the management of type 2 diabetes.
   Nauck MA. · · 2014 · cited 227× · PMID 25246775 · DOI 10.2147/dddt.s50773
2. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials.
   Levine MJ. · · 2017 · cited 44× · PMID 27296042 · DOI 10.2174/1573399812666160613113556
3. The SGLT2 Inhibitor Empagliflozin for the Treatment of Type 2 Diabetes Mellitus: a Bench to Bedside Review.
   McGill JB. · · 2014 · cited 32× · PMID 24729157 · DOI 10.1007/s13300-014-0063-1
4. Empagliflozin: a new sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
   Neumiller JJ. · · 2014 · cited 29× · PMID 24991224 · DOI 10.7573/dic.212262
5. Comparative effectiveness of oral antidiabetic drugs in preventing cardiovascular mortality and morbidity: A network meta-analysis.
   Lee G, Oh SW, Hwang SS, Yoon JW, et al · · 2017 · cited 25× · PMID 28542373 · DOI 10.1371/journal.pone.0177646
6. SGLT-2i and Risk of Malignancy in Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.
   Shi N, Shi Y, Xu J, Si Y, et al · · 2021 · cited 24× · PMID 34164370 · DOI 10.3389/fpubh.2021.668368
7. Relationship Between SGLT-2i and Ocular Diseases in Patients With Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials.
   Zhou B, Shi Y, Fu R, Ni H, et al · · 2022 · cited 19× · PMID 35692406 · DOI 10.3389/fendo.2022.907340
8. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials.
   Shiba T, Ishii S, Okamura T, Mitsuyoshi R, et al · · 2017 · cited 9× · PMID 28753486 · DOI 10.1016/j.diabres.2017.07.004