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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

About this Study

This study will assess the effectiveness and long term safety of empagliflozin and linagliptin versus placebo in children and adolescents with type 2 diabetes mellitus.

Sponsor Protocol ID:1218-0091
IRB Number:2019-0166
Study Status:

Study Status

Actively Enrolling: The study is currently recruiting participants.

Closed for Enrollment: The study is not currently recruiting participants.

Actively Enrolling
Study Type:

Study Type

Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.

Interventional
Study Phase:

Study Phase

Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Phase 3
Online Start Date:

Online Start Date

The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.

August 26, 2019
Eligibility Criteria
Minimum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

10 years old
Maximum Age

Age Requirement

Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.

17 years old
Biological Sex

Biological Sex Requirement

Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

 Both Male and Female
Cancer Related?

Cancer Related

Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

No
Pediatric Related?

Pediatric Related

Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.

Yes
Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Indicates whether people who do not have the condition/disease being studied can participate in the clinical study.

Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.

No

Inclusion Criteria Patients from 10 to 17 years of age (inclusive) at the time of randomisation (Visit 2) 

 Patients with type 2 diabetes mellitus for at least 12 weeks at Visit 1A 

 Insufficient glycaemic control (HbA1c ≥ 6.5% and ≤ 10.5%) as measured by the central laboratory at Visit 1A 

 Patients treated with diet and exercise and metformin at a stable dose for 8 weeks prior to randomisation and/or stable insulin therapy (basal or MDI) for 8 weeks prior to randomisation (stable insulin therapy is defined as a weekly average variation of the basal insulin dose ≤ 0.1 IU/kg over 8 weeks prior to randomisation) Patients not tolerating metformin and treated with diet and exercise only are also eligible for inclusion 

 BMI ≥ 85th percentile according to WHO references at Visit 1B 

 Negative for islet cell antigen auto-antibodies (IA-2) and glutamic acid decarboxylase (GAD) auto-antibodies as measured by the central laboratory at Visit 1A

 Non-fasting serum C-peptide levels ≥ 0.6 ng/ml as measured by the central laboratory at Visit 1A

Exclusion Criteria History of acute metabolic decompensation such as diabetic ketoacidosis within 8 weeks prior to Visit 1A 

 Diagnosis of monogenic diabetes (e.g. MODY) 

 Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR)

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Palliative Care
Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Children’s of Mississippi - Batson Kids Clinic
Contact Information
Contact Name: Angelena Sharp
Phone Number: 601-815-9282
Email: asharp@umc.edu
Principal Investigator:Dixit, Naznin M, M.D.
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