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Sodium-glucose cotransporter 2 (SGLT2) Inhibitor

Empagliflozin for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 395 days.
Awards & highlights

Study Summary

This trial will be conducted in 2 parts: a run-in phase and a treatment phase. The run-in phase is designed to ensure that patients are able to take the study drugs as described in the protocol. After the run-in phase, there will be a 26-week treatment phase, during which patients will be randomly assigned to receive one of the 3 study treatments: empagliflozin 10 mg, empagliflozin 25 mg, or linagliptin 5 mg. Following the treatment phase, there will be a 26-week safety extension phase, during which patients will continue on the same treatment they were receiving

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 395 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 395 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycated Haemoglobin (HbA1c) (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ
Percentage of Patients With Treatment Failure up to or at Week 26
Secondary outcome measures
Change in Body Weight (kg) From Baseline to the End of 26 Weeks
Change in Diastolic Blood Pressure (DBP, mmHg) From Baseline to the End of 26 Weeks
Change in Fasting Plasma Glucose (FPG, mg/dL) From Baseline to the End of 26 Weeks
+5 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Cardiac failure chronic
1%
Myocardial infarction
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo - Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment4 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily, until end of treatment.
Group II: Placebo - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment4 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily. At week 26, patients were re-randomised to receive 25 milligram (mg) empagliflozin, taken once daily, until end of treatment.
Group III: Placebo - Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment4 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily. At week 26, patients were re-randomised to receive 10 milligram (mg) empagliflozin, taken once daily, until end of treatment.
Group IV: Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment3 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily, until end of treatment.
Group V: Empagliflozin 10 mg - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment3 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily until Week 14. Non responder patients were re-randomised at Week 14 to receive 25 mg empagliflozin, taken once daily, until end of treatment.
Group VI: Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimental Treatment3 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily, until Week 14. Responder patients were not re-randomised at week 14 and continued 10 mg empagliflozin, taken once daily, until end of treatment. Non responder patients were re-randomised at Week 14 to receive 10 mg empagliflozin, taken once daily, until end of treatment.
Group VII: Placebo - DINAMOᵀᴹ & DINAMOᵀᴹ MonoPlacebo Group3 Interventions
Patients treated with metformin and/or insulin or patients who do not tolerate metformin or treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily, until end of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Insulin
2000
Completed Phase 4
~4280
Empagliflozin
2017
Completed Phase 4
~181750
Placebo
1995
Completed Phase 3
~2670
Linagliptin
2010
Completed Phase 4
~19930

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,502 Previous Clinical Trials
11,339,771 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions still available for participants in this clinical trial?

"No, this particular clinical trial is not currently looking for participants. Although, it should be noted that the date of the last edit to this posting was November 17th, 2022. There are 1508 other trials which are actively recruiting patients."

Answered by AI

Are there any other research papers that mention Empagliflozin?

"Empagliflozin was first trialed in 2017 by Universidad de Navarra - Clinica Universitaria de Navarra (CUN). Out of the 18506 completed studies, 53 are still actively recruiting patients. Many of these locations are situated in Buffalo, New york."

Answered by AI

Is this trial popular in North America?

"There are 41 clinical trial sites currently accepting patients for this study, which include UBMD Pediatrics in Buffalo, New york, Oceane7 Clinical Research in Miami, Florida, and The Hospital for Sick Children in Toronto, Ontario."

Answered by AI

What is the most common reason that doctors prescribe Empagliflozin?

"Empagliflozin is often used to treat cardiovascular diseases. However, this medication can also help patients who are struggling with heart failure, type 2 diabetes mellitus, and cardiovascular mortality."

Answered by AI

Can octogenarians participate in this experiment?

"As this trial is for minors, only patients aged 10-17 can apply. Out of the 1472 clinical trials hosted on this website, 203 are for people under 18 and 1169 arefor those over 65 years old."

Answered by AI

Has Empagliflozin been cleared by the FDA?

"Empagliflozin's safety is estimated to be a 3. This is due to the fact that it is a Phase 3 trial, and thus there is data supporting both its efficacy and safety."

Answered by AI

How many individuals are being included in this experiment?

"This study is no longer recruiting patients. The clinical trial was first posted on 3/20/2018 and most recently updated on 11/17/2022. If the patient is exploring other studies, there are currently 1455 clinical trials actively looking for patients with diabetes mellitus, type 2 and 53 trials for Empagliflozin actively recruiting participants."

Answered by AI

What makes this research unique compared to other similar investigations?

"Empagliflozin has had 53 clinical trials in 43 countries and 246 cities since its initial trial in 2017. The first study, sponsored by Hoffmann-La Roche, was a Phase 1 & 2 drug approval stage that involved 410 participants. Since the completion of the original trial, 18506 more have been conducted."

Answered by AI

How can I sign up to participate in this research?

"This clinical trial is recruiting people aged 10-17 who have type 2 diabetes mellitus. Candidates must meet the following criteria: they must be dieting and exercising, plus taking a stable dose of metformin for 8 weeks prior to Visit 2 OR not tolerating metformin (defined as patients who were on metformin treatment for at least 1 week and had to discontinue metformin due to metformin-related side effects as assessed by the investigator) AND/OR diet and exercise plus stable basal or MDI insulin therapy,, defined as a weekly average variation of the basal insulin dose ≤ 0.1"

Answered by AI

Who else is applying?

What state do they live in?
New York
Arizona
California
Other
How old are they?
18 - 65
65+
What site did they apply to?
Phoenix Children's Hospital
Rady Children's Hospital - San Diego
University of Iowa Hospitals and Clinics
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

What questions have other patients asked about this trial?

What's the compensation, trial length?
PatientReceived no prior treatments

Why did patients apply to this trial?

Nothing seems to be working.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM
2018. "Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03429543.
~25 spots leftby Apr 2025
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