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Diabetes Mellitus, Type 2Phase 3NCT03429543

Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM

A Phase 3 study testing Metformin, Insulin and Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 83 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin, Insulin and Linagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
83 sitesin 14 countries
Study dates
20 Mar 2018to 31 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
  • DINAMO TM: Documented diagnosis of T2DM for at least 8 weeks at Visit 1A
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  • DINAMO TM Mono: Confirmation of T2DM at Visit 1A
  • Insufficient glycaemic control as measured by the central laboratory at Visit 1A:
  • DINAMO TM: HbA1c ≥ 6.5% and ≤ 10.5%
  • DINAMO TM Mono: HbA1c ≥ 6.5% and ≤ 9.0%
  • DINAMO TM: Patients treated with
  • diet and exercise plus metformin at a stable dose 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 IU/kg over 8 weeks prior to Visit 2. - DINAMOTM Mono: Drug-naïve patients or patients not on active treatment (including discontinuation of metformin due to intolerance [or previous discontinuation for other reasons] and/or discontinuation of insulin [insulin use must be 8 weeks or less] at investigator's discretion) prior to or at Visit 1A)
  • 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

Who cannot join

  • Any history of acute metabolic decompensation such as diabetic ketoacidosis within 8 weeks prior to Visit 1A and up to randomisation (mild to moderate polyuria at the time of randomisation is acceptable)
  • Diagnosis of monogenic diabetes (e.g. MODY)
  • History of pancreatitis
  • Diagnosis of metabolic bone disease
  • Gastrointestinal disorders that might interfere with study drug absorption according to investigator assessment
  • Secondary obesity as part of a syndrome (e.g. Prader-Willi syndrome)
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  • Any antidiabetic medication (with the exception of metformin and/or insulin background therapy) within 8 weeks prior to Visit 1A and until Visit 2
  • Treatment with weight reduction medications (including anti-obesity drugs) within 3 months prior to Visit 1A and until Visit 2
  • History of weight-loss surgery or current aggressive diet regimen (according to investigator assessment) at Visit 1A and until Visit 2
  • Treatment with systemic corticosteroids for > 1 week within 4 weeks prior to Visit 1A and up to Visit 2 Inhaled or topical use of corticosteroids (e.g. for asthma/chronic obstructive pulmonary disease) is acceptable.
  • Change in dose of thyroid hormones within 6 weeks prior to Visit 1A or planned change or initiation of such therapy before Visit 2
  • Known hypersensitivity or allergy to the investigational products or their excipients
  • Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m² (according to Zappitelli formula) as measured by the central laboratory at Visit 1A
  • Indication of liver disease defined by serum level of either alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase above 3 fold upper limit of normal (ULN) at Visit 1A as measured by the central laboratory at Visit 1A
  • History of belonephobia (needle phobia)
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1A, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
  • Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
  • Any other acute or chronic medical or psychiatric condition or laboratory abnormality that, based on investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome
  • Medical contraindications to metformin according to the local label (for patient on metformin background therapy)
  • Patient not able or cannot be supported by his/her parent(s) or legal guardian to understand and comply with study requirements based on investigator's judgement
  • Previous randomisation in this trial
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
  • Chronic alcohol or drug abuse within 3 months prior to Visit 1A or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial
  • Female patients who are pregnant, nursing, or who plan to become pregnant in the trial

Trial locations and contacts

83 sites in 14 countries.

83 sites in 14 countries

United States44 sites

  • Children's Center for Advanced Pediatrics

    Atlanta, Georgia, 30329

  • Atlanta Center

    Atlanta, Georgia, 30331

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • UBMD Pediatrics

    Buffalo, New York, 14203

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Integrative Biosciences Center

    Detroit, Michigan, 48202

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

  • Office of Amir A. Hassan, MD, P.A.

    Houston, Texas, 77089

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

  • Saenz Medical Center

    La Joya, Texas, 78560

  • Novak Center for Children's Health

    Louisville, Kentucky, 40202

  • LifeDoc Research, PLLC

    Memphis, Tennessee, 38119

  • Oceane7 Clinical Research

    Miami, Florida, 33144

  • Empire Clinical Research, LLC

    Miami Lakes, Florida, 33016

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • New York University Langone Medical Center

    New York, New York, 10016

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • CHOC Children's Hospital

    Orange, California, 92868

  • Pediatric and Adult Research Center

    Orlando, Florida, 32825

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Nemours Clinic

    Pensacola, Florida, 32514

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota, 57701

  • Children's Hospital of Richmond at VCU

    Richmond, Virginia, 23219

  • Texas Diabetes Institute

    San Antonio, Texas, 78207

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94158

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33612

  • Advantage Clinical Trials

    The Bronx, New York, 10468

  • University of Arizona

    Tucson, Arizona, 85724

  • University of Oklahoma

    Tulsa, Oklahoma, 74135

  • AdventHealth Medical Group, Pediatric Diabetes and Endocrinology at Winter Park

    Winter Park, Florida, 32789

Other trials in United States

Russia11 sites

  • Regional Clinical Hospital 'The Badge of Honor Order'

    Irkutsk, 664049

  • Ivanovo Reg.Clin.Hosp.

    Ivanovo, 153040

  • Rep.childrens clin.hosp.

    Izhevsk, 426009

  • State Medical University, Kazan

    Kazan', 420012

  • Munic. Instit. of HC "Kirov clin. hosp.#7 n.a.V.I.Urlova"

    Kirov, 610014

  • Endocrinology Scientific Center, MoH and Social Development

    Moscow, 117036

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630091

  • Fed. State Budget Educational Instit. of Higher Education "Rostov State Med. Univ." of MoH of RF

    Rostov-on-Don, 344022

  • St. Petersburg State Pediatric University

    Saint Petersburg, 194100

  • Siberian State Med.Uni,Faculty Therapy Dep.w/ Clin.Pharmacol

    Tomsk, 634050

  • Bahkir state med. Univ. of the Ministry Polyclinic Pediatric

    Ufa, 450106

Other trials in Russia

Mexico6 sites

  • Investigación en Salud y Metabolismo S.C.

    Chihuahua City, 31217

  • Centro de Estudios de Investigación Metabólicos y Cardiovasculares, S.C.

    Ciudad Madero, 89440

  • CAIMED Investigacion en Salud, S.A. de C.V.

    Mexico City, 06760

  • Consultorio Medico

    Puebla City, 72190

  • Investigacion Medica Sonora S.C.

    Sonora, 83280

  • Centro de Investigación Médica de Ocidente, S.C.

    Zapopan, 45116

Other trials in Mexico

Israel3 sites

  • Soroka Univ. Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 31096

  • The Chaim Sheba Medical Center Tel HaShomer

    Ramat Gan, 5265601

Other trials in Israel

South Korea3 sites

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Argentina2 sites

  • Sanatorio Allende S.A.

    Nueva Córdoba, X5000JHQ

  • Hospital de Clínicas Pte. Dr. Nicolás Avellaneda

    San Miguel de Tucumán, 4000

Other trials in Argentina

Brazil2 sites

  • Instituto de Estudos e Pesquisas Clínicas IEP-CE

    Fortaleza, 60160-230

  • Fundacao de Apoio ao Ensino, Pesquisa e Assistencia do Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14048-900

Other trials in Brazil

Canada2 sites

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • University of Manitoba - Health Sciences Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

China2 sites

  • The First Hospital of Jilin University

    Changchun, 130021

  • Zhengzhou Children'S Hospital

    Zhengzhou, 450017

Other trials in China

Colombia2 sites

  • Centro de Diabetes Cardiovascular IPS

    Barranquilla, 80020

  • Dexa-Diab IPS

    Bogotá DC, 110221

Other trials in Colombia

Thailand2 sites

  • Rajavithi Hospital

    Bangkok, 10400

  • Srinagarind Hospital

    Khon Kaen, 40002

Other trials in Thailand

United Kingdom2 sites

  • St George's Hospital

    London, SW17 0QT

  • Royal Berkshire Hospital

    Reading, RG1 5AN

Other trials in United Kingdom

Germany1 site

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

Other trials in Germany

Puerto Rico1 site

  • San Juan Bautista School of Medicine

    Caguas, 00726

Other trials in Puerto Rico

About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Empagliflozin and Linagliptin Over 26 Weeks, With a Double-blind Active Treatment Safety Extension Period up to 52 Weeks, in Children and Adolescents With Type 2 Diabetes Mellitus

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.

Read more

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.

Being tested
Metformin, Insulin, Placebo, Linagliptin, Empagliflozin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    At least 1000 mg/day or up to a maximal tolerated dose.

  • InsulinDrug

    Basal or multiple dose injection.

  • PlaceboDrug

    1 film-coated tablet of either Linagliptin or Empagliflozin matched placebo once daily.

  • LinagliptinDrug

    Also called Trajenta(R)

    1 film-coated tablet Linagliptin once daily, until end of treatment.

  • EmpagliflozinDrug

    Also called Jardiance(R)

    1 film-coated tablet of Empagliflozin once daily, until end of treatment.

Study groups in NCT03429543
Study groupRoleWhat they receive
Placebo - DINAMOᵀᴹ & DINAMOᵀᴹ MonoPlacebo comparatorPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Placebo
Placebo - Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Placebo; Drug: Linagliptin
Placebo - Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Placebo; Drug: Empagliflozin
Placebo - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Placebo; Drug: Empagliflozin
Linagliptin 5 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Linagliptin
Empagliflozin 10 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Empagliflozin
Empagliflozin 10 mg - Empagliflozin 25 mg - DINAMOᵀᴹ & DINAMOᵀᴹ MonoExperimentalPatients 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.
Receives: Drug: Metformin; Drug: Insulin; Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 1) and week 26 of treatment.

  2. 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:

    • Use of rescue medication at any time up to Week 26
    • Increase from baseline in HbA1c by 0.5% at Week 26 . Increase from baseline in HbA1c to above 7.0% at Week 26 in patients with baseline HbA1c <7.0%

    Measured: Up to 26 weeks.

Secondary outcomes (8)

  1. 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.

    Measured: Baseline (Day 1) and week 26 of treatment.

  2. 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.

    Measured: Up to 395 days.

  3. 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.

    Measured: Baseline (Day 1) and week 26.

  4. 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.

    Measured: Baseline (Day 1) and week 26.

  5. 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.

    Measured: Baseline (Day 1) and week 26.

  6. 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.

    Measured: Baseline (Day 1) and week 26.

  7. 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.

    Measured: Baseline (Day 1) and week 26.

  8. 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.

    Measured: Baseline (Day 1) and week 26.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start20 Mar 2018
  3. Primary completion19 Oct 2022
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03429543
Sponsor's protocol ID
1218-0091
Other IDs
2016-000669-21, 2016
Status last verified
Feb 2024
First submitted
6 Feb 2018
Last updated
23 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36738751

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin, Insulin and Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 83 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Russia, Mexico, Israel, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (%) From Baseline to the End of 26 Weeks - DINAMOᵀᴹ (time frame: Baseline (Day 1) and week 26 of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03429543, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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