Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000669-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) .
Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population.
Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation.
Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines.
Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels.
The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive.
Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment".
For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55.
On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin.
After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated.
Following the treatment phases, there will be a follow-up visit at week 55
Intervention model description:
Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Placebo Comparator | 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. |
|
| Placebo - Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
|
| Placebo - Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
|
| Placebo - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | At least 1000 mg/day or up to a maximal tolerated dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ | Adjusted means taken from the following three models, as pre-specified in the protocol: Treatment group 1 (TG1): [Placebo], [Linagliptin 5mg] and [Empagliflozin pooled] Treatment group 2 (TG2): [Placebo] and [Empagliflozin 10mg and 10+25mg] Treatment group 3 (TG3): [Placebo] and [Empagliflozin 10mg] ANCOVA with continuous covariate (baseline HbA1c) and categorical covariates (treatment & age). Effect of linagliptin and of empagliflozin was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing. After having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo (TG2 & TG3). ANCOVA utilized a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise. | Baseline (Day 1) and week 26 of treatment. |
| Percentage of Patients With Treatment Failure up to or at Week 26 | Percentage of patients with treatment failure up to or at Week 26 as a binary endpoint, defined as meeting at least one of the following criteria:
| Up to 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ Mono | Change in Glycated haemoglobin (HbA1c) (%) from baseline to the end of 26 weeks. Adjusted values came from a restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Analyses included fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. |
Not provided
Inclusion Criteria:
Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit 2)
Male and female patients
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient's legal representative information sheet.
Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with ICH-GCP and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence and capacity)
Documented diagnosis of T2DM at Visit 1A:
Insufficient glycaemic control as measured by the central laboratory at Visit 1A:
DINAMO TM: Patients treated with
BMI ≥ 85th percentile for age and sex according to WHO references at Visit 1B
Non-fasting serum C-peptide levels ≥ 0.6 ng/ml as measured by the central laboratory at Visit 1A
Compliance with trial medication intake must be between 75% and 125% during the open-label placebo run-in period
Further inclusion criteria apply
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36738751 | Derived | Laffel LM, Danne T, Klingensmith GJ, Tamborlane WV, Willi S, Zeitler P, Neubacher D, Marquard J; DINAMO Study Group. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):169-181. doi: 10.1016/S2213-8587(22)00387-4. Epub 2023 Feb 1. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was a randomised, placebo-controlled, double-blind, and parallel group trial with 3 treatment arms (placebo, 5 mg linagliptin, 10 mg empagliflozin). The main trial DINAMOᵀᴹ consisted of patients treated with metformin and/or insulin or patients who do not tolerate metformin. The ancillary trial DINAMOᵀᴹ Mono consisted of treatment-naïve patients or patients not on active treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2022 | Nov 28, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
|
| Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
|
| Empagliflozin 10 mg - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Experimental | 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. |
|
| Insulin | Drug | Basal or multiple dose injection. |
|
| Placebo | Drug | 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily. |
|
| Linagliptin | Drug | 1 film-coated tablet Linagliptin once daily, until end of treatment. |
|
|
| Empagliflozin | Drug | 1 film-coated tablet of Empagliflozin once daily, until end of treatment. |
|
|
| Baseline (Day 1) and week 26 of treatment. |
| Time to Treatment Failure | Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study (Week 52). Patients in the placebo group were censored after 26 weeks unless a prior treatment failure was observed. | Up to 395 days. |
| Change in Fasting Plasma Glucose (FPG, mg/dL) From Baseline to the End of 26 Weeks | Change in fasting plasma glucose (FPG, Milligrams Per Deciliter (mg/dL)) from baseline to the end of 26 weeks. Adjusted values taken from analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed. | Baseline (Day 1) and week 26. |
| Change in Body Weight (kg) From Baseline to the End of 26 Weeks | Change in body weight (kg) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | Baseline (Day 1) and week 26. |
| Change in Systolic Blood Pressure (SBP, mmHg) From Baseline to the End of 26 Weeks | Change in systolic blood pressure (SBP, millimeters of mercury (mmHg)) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | Baseline (Day 1) and week 26. |
| Change in Diastolic Blood Pressure (DBP, mmHg) From Baseline to the End of 26 Weeks | Change in diastolic blood pressure (DBP, millimeters of mercury (mmHg)) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | Baseline (Day 1) and week 26. |
| Percentage of Patients Who Achieve HbA1c <6.5% at the End of 26 Weeks | Percentage of patients who achieve HbA1c <6.5% at the end of 26 weeks. | Baseline (Day 1) and week 26. |
| Percentage of Patients Who Achieve HbA1c <7.0% at the End of 26 Weeks | Percentage of patients who achieve HbA1c <7.0% at the end of 26 weeks. | Baseline (Day 1) and week 26. |
| Tucson |
| Arizona |
| 85724 |
| United States |
| CHOC Children's Hospital | Orange | California | 92868 | United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | United States |
| Oceane7 Clinical Research | Miami | Florida | 33144 | United States |
| Empire Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| Pediatric and Adult Research Center | Orlando | Florida | 32825 | United States |
| Nemours Clinic | Pensacola | Florida | 32514 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| AdventHealth Medical Group, Pediatric Diabetes and Endocrinology at Winter Park | Winter Park | Florida | 32789 | United States |
| Children's Center for Advanced Pediatrics | Atlanta | Georgia | 30329 | United States |
| Atlanta Center | Atlanta | Georgia | 30331 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Novak Center for Children's Health | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Integrative Biosciences Center | Detroit | Michigan | 48202 | United States |
| University Of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| University of Oklahoma | Tulsa | Oklahoma | 74135 | United States |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Monument Health Rapid City Hospital, Inc. | Rapid City | South Dakota | 57701 | United States |
| LifeDoc Research, PLLC | Memphis | Tennessee | 38119 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Office of Amir A. Hassan, MD, P.A. | Houston | Texas | 77089 | United States |
| Saenz Medical Center | La Joya | Texas | 78560 | United States |
| Texas Diabetes Institute | San Antonio | Texas | 78207 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23219 | United States |
| Sanatorio Allende S.A. | Nueva Córdoba | X5000JHQ | Argentina |
| Hospital de Clínicas Pte. Dr. Nicolás Avellaneda | San Miguel de Tucumán | 4000 | Argentina |
| Instituto de Estudos e Pesquisas Clínicas IEP-CE | Fortaleza | 60160-230 | Brazil |
| Fundacao de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto | Ribeirão Preto | 14048-900 | Brazil |
| University of Manitoba - Health Sciences Centre | Winnipeg | Manitoba | R3E 3P4 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Zhengzhou Children'S Hospital | Zhengzhou | 450017 | China |
| Centro de Diabetes Cardiovascular IPS | Barranquilla | 80020 | Colombia |
| Dexa-Diab IPS | Bogotá DC | 110221 | Colombia |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Soroka Univ. Medical Center | Beersheba | 84101 | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| The Chaim Sheba Medical Center Tel HaShomer | Ramat Gan | 5265601 | Israel |
| Investigación en Salud y Metabolismo S.C. | Chihuahua City | 31217 | Mexico |
| Centro de Estudios de Investigación Metabólicos y Cardiovasculares, S.C. | Ciudad Madero | 89440 | Mexico |
| CAIMED Investigacion en Salud, S.A. de C.V. | Mexico City | 06760 | Mexico |
| Consultorio Medico | Puebla City | 72190 | Mexico |
| Investigacion Medica Sonora S.C. | Sonora | 83280 | Mexico |
| Centro de Investigación Médica de Ocidente, S.C. | Zapopan | 45116 | Mexico |
| San Juan Bautista School of Medicine | Caguas | 00726 | Puerto Rico |
| Regional Clinical Hospital 'The Badge of Honor Order' | Irkutsk | 664049 | Russia |
| Ivanovo Reg.Clin.Hosp. | Ivanovo | 153040 | Russia |
| Rep.childrens clin.hosp. | Izhevsk | 426009 | Russia |
| State Medical University, Kazan | Kazan' | 420012 | Russia |
| Munic. Instit. of HC "Kirov clin. hosp.#7 n.a.V.I.Urlova" | Kirov | 610014 | Russia |
| Endocrinology Scientific Center, MoH and Social Development | Moscow | 117036 | Russia |
| State Novosibirsk Regional Clinical Hospital | Novosibirsk | 630091 | Russia |
| Fed. State Budget Educational Instit. of Higher Education "Rostov State Med. Univ." of MoH of RF | Rostov-on-Don | 344022 | Russia |
| St. Petersburg State Pediatric University | Saint Petersburg | 194100 | Russia |
| Siberian State Med.Uni,Faculty Therapy Dep.w/ Clin.Pharmacol | Tomsk | 634050 | Russia |
| Bahkir state med. Univ. of the Ministry Polyclinic Pediatric | Ufa | 450106 | Russia |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Placebo - Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono |
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 5 milligram (mg) Linagliptin, taken once daily, until end of treatment. |
| FG002 | Placebo - Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| FG003 | Placebo - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| FG004 | Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| FG005 | Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| FG006 | Empagliflozin 10 mg - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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 who started on 10 milligram (mg) empagliflozin, taken once daily, who did not respond at Week 12 and were re-randomised at week 14 to receive 25 mg empagliflozin, taken once daily, until end of treatment. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomised set (RS) included all randomised patients, regardless whether they took trial medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| BG001 | Placebo - Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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 5 milligram (mg) Linagliptin, taken once daily, until end of treatment. |
| BG002 | Placebo - Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| BG003 | Placebo - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| BG004 | Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| BG005 | Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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. |
| BG006 | Empagliflozin 10 mg - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | 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 who started on 10 milligram (mg) empagliflozin, taken once daily, who did not respond at Week 12 and were re-randomised at week 14 to receive 25 mg empagliflozin, taken once daily, until end of treatment. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| HbA1c | HbA1c percentage | The treated set (TS) included all patients treated with at least 1 dose of randomised trial medication. | Mean | Standard Deviation | percentage |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycated Haemoglobin (HbA1c) (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ | Adjusted means taken from the following three models, as pre-specified in the protocol: Treatment group 1 (TG1): [Placebo], [Linagliptin 5mg] and [Empagliflozin pooled] Treatment group 2 (TG2): [Placebo] and [Empagliflozin 10mg and 10+25mg] Treatment group 3 (TG3): [Placebo] and [Empagliflozin 10mg] ANCOVA with continuous covariate (baseline HbA1c) and categorical covariates (treatment & age). Effect of linagliptin and of empagliflozin was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing. After having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo (TG2 & TG3). ANCOVA utilized a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise. | Patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All data as observed were included. Any data after start of rescue medication and any on- and post-treatment values were kept. As pre-specified in the Protocol, endpoint only includes the DINAMOᵀᴹ data, subjects randomized to Empagliflozin were grouped in pre-specified treatment analysis groups (TG1, TG2, TG3) for hypotheses testing, data was not analyzed per individual arm. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Day 1) and week 26 of treatment. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Treatment Failure up to or at Week 26 | Percentage of patients with treatment failure up to or at Week 26 as a binary endpoint, defined as meeting at least one of the following criteria:
| The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. Missing values were regarded as 'treatment failures'. As pre-specified in the Protocol, endpoint only includes the ancillary study (DINAMOᵀᴹ Mono) data. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Up to 26 weeks. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ Mono | Change in Glycated haemoglobin (HbA1c) (%) from baseline to the end of 26 weeks. Adjusted values came from a restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Analyses included fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All available data as observed were included. Any values after start of rescue medication and any on- and post-treatment values were kept. As pre-specified in the Protocol, endpoint only includes the ancillary study (DINAMOᵀᴹ Mono) data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline (Day 1) and week 26 of treatment. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure | Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study (Week 52). Patients in the placebo group were censored after 26 weeks unless a prior treatment failure was observed. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. Missing values were regarded as 'failures'. As pre-specified in the Protocol, endpoint only includes the ancillary study (DINAMOᵀᴹ Mono) data. | Posted | Mean | Standard Error | Days | Up to 395 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose (FPG, mg/dL) From Baseline to the End of 26 Weeks | Change in fasting plasma glucose (FPG, Milligrams Per Deciliter (mg/dL)) from baseline to the end of 26 weeks. Adjusted values taken from analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All available data as observed were included. Any values after start of rescue medication and any on- and post-treatment values were kept, baseline observations were carried forward to impute the missing data. Only patients with non-missing data were included. | Posted | Least Squares Mean | 95% Confidence Interval | Milligrams Per Deciliter (mg/dL) | Baseline (Day 1) and week 26. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight (kg) From Baseline to the End of 26 Weeks | Change in body weight (kg) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All available data as observed were included. Any values after start of rescue medication and any on- and post-treatment values were kept. Only patients with non-missing data were included. | Posted | Least Squares Mean | 95% Confidence Interval | kilogram (kg) | Baseline (Day 1) and week 26. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure (SBP, mmHg) From Baseline to the End of 26 Weeks | Change in systolic blood pressure (SBP, millimeters of mercury (mmHg)) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All available data as observed were included. Any values after start of rescue medication and any on- and post-treatment values were kept. Only patients with non-missing data were included. | Posted | Least Squares Mean | 95% Confidence Interval | millimeters of mercury (mmHg) | Baseline (Day 1) and week 26. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Diastolic Blood Pressure (DBP, mmHg) From Baseline to the End of 26 Weeks | Change in diastolic blood pressure (DBP, millimeters of mercury (mmHg)) from baseline to the end of 26 weeks. Adjusted values taken from mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. All available data as observed were included. Any values after start of rescue medication and any on- and post-treatment values were kept. Only patients with non-missing data were included. | Posted | Least Squares Mean | 95% Confidence Interval | millimeters of mercury (mmHg) | Baseline (Day 1) and week 26. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Achieve HbA1c <6.5% at the End of 26 Weeks | Percentage of patients who achieve HbA1c <6.5% at the end of 26 weeks. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. Missing values were regarded as 'failures'. | Posted | Number | Percentage of subjects | Baseline (Day 1) and week 26. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Achieve HbA1c <7.0% at the End of 26 Weeks | Percentage of patients who achieve HbA1c <7.0% at the end of 26 weeks. | The modified intention-to-treat set (mITT) included all patients treated with at least 1 dose of trial medication who had a baseline HbA1c measurement. Missing values were regarded as 'failures'. | Posted | Number | Percentage of subjects | Baseline (Day 1) and week 26. |
|
Date of first study drug intake until date of last active study drug intake + residual effect period (7 days), up to 402 days.
The treated set (TS) included all patients treated with at least 1 dose of randomised trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Pooled - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Patients from either DINAMOᵀᴹ or DINAMOᵀᴹ Mono randomized to Placebo. | 0 | 58 | 2 | 58 | 30 | 58 |
| EG001 | Linagliptin 5 mg Pooled - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Patients from either DINAMOᵀᴹ or DINAMOᵀᴹ Mono who either started on Linagliptin or who switched to Linagliptin from Placebo at week 26. 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. | 0 | 77 | 8 | 77 | 45 | 77 |
| EG002 | Empagliflozin 10 mg Pooled - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Patients from either DINAMOᵀᴹ or DINAMOᵀᴹ Mono who either started on 10 mg Empagliflozin or switched to 10 mg Empagliflozin from Placebo at week 26. 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. | 0 | 74 | 4 | 74 | 47 | 74 |
| EG003 | Empagliflozin 25 mg Pooled - DINAMOᵀᴹ & DINAMOᵀᴹ Mono | Patients from either DINAMOᵀᴹ or DINAMOᵀᴹ Mono who were on Placebo and switched to 25 mg Empagliflozin following re-randomisation at week 26 or who were on 10 mg Empagliflozin and switched to 25 mg Empagliflozin following re-randomisation at week 14. 1 film-coated tablet of 25 mg empagliflozin, taken once daily, until end of treatment. | 0 | 29 | 0 | 29 | 14 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenic vein thrombosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Chorioretinitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood ketone body increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2022 | Nov 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D007328 | Insulin |
| D000069476 | Linagliptin |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
|
|
|
|
|
| Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing. | ANCOVA | 0.0116 | Mean Difference (Final Values) | -0.84 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -1.50 | -0.19 | Mean difference calculated as [Treatment] - Placebo. | Other |
| Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing. | ANCOVA | 0.1943 | Mean Difference (Final Values) | -0.52 | Standard Error of the Mean | 0.40 | 2-Sided | 95 | -1.31 | 0.27 | Mean difference calculated as [Treatment] - Placebo. | Other | Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise. |
| Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing. | ANCOVA | 0.0015 | Mean Difference (Final Values) | -1.18 | Standard Error of the Mean | 0.37 | 2-Sided | 95 | -1.90 | -0.45 | Mean difference calculated as [Treatment] - Placebo. | Other | Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise. |
Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily.
| OG002 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA1c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment.
|
|
|
| OG002 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ | Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA1c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
| OG003 | Placebo - DINAMOᵀᴹ Mono | Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily. At week 26, patients on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
| OG002 | Empagliflozin Pooled (10 mg and 25 mg) | Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA1c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
| OG003 | Placebo - DINAMOᵀᴹ Mono | 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 on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
| OG002 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ | Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA1c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
| OG003 | Placebo - DINAMOᵀᴹ Mono | 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 on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
| OG002 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ | Patients treated with metformin and/or insulin or patients who do not tolerate metformin took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA1c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
| OG003 | Placebo - DINAMOᵀᴹ Mono | 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 on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
| OG003 | Placebo - DINAMOᵀᴹ Mono | 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 on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|
| OG003 | Placebo - DINAMOᵀᴹ Mono | 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 on placebo were re-randomised to receive either 5 mg linagliptin or 10 mg empagliflozin or 25 mg empagliflozin in a 1:1:1 ratio, taken once daily, until end of treatment. |
| OG004 | Linagliptin 5 mg - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 5 milligram (mg) Linagliptin once daily. |
| OG005 | Empagliflozin Pooled (10 mg and 25 mg) - DINAMOᵀᴹ Mono | Treatment-naïve patients or patients who are not on active treatment took 1 film-coated tablet of 10 milligram (mg) Empagliflozin once daily. Patients who did not achieve an HbA₁c value <7% at Week 12, were re-randomised to receive either 10 mg or 25 mg empagliflozin in a 1:1 ratio, taken once daily, until end of treatment. |
|
|
|