Diabetes Mellitus, Type 2Phase 3NCT03015519
A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing Albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a… 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?
- Albiglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Aug 2017to 20 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Between 10 to less than 18 years of age inclusive at the time of screening.
- Diagnosis of T2DM with HbA1c more than or equal to 7.0% [53 millimole per mole (mmol/mol)] and less than 10.0% (85.8 mmol/mol) assessed at screening. Currently treated with regimen of diet and exercise with or without metformin. Subjects on metformin monotherapy should have been treated for a minimum of 8 weeks prior to randomization on a dose above 1000 milligram per day (mg/day) or prior documented maximum tolerated dose (MTD) less than or equal to 1000 mg/day.
- FPG less than 240 mg/deciliter (dL) at screening.
- Fasting C-peptide more than or equal to 0.8 nanogram per milliliter (ng/mL) at screening.
- Negative central laboratory assays for Glutamic Acid Decarboxylase 65 (GAD-65) and Islet Cell Autoantigen 512 (ICA512) autoantibodies at screening.
- Body weight more than or equal to 30 kilogram (kg) at screening.
- Male subjects will be included. Female subjects who have achieved menarche and are of childbearing potential must be practicing adequate contraception for the duration of participation in the study.
- Signed informed consent of parent or legal guardian and assent as appropriate will be obtained from the child.
Who cannot join
- Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
- Female subject is pregnant (confirmed by laboratory testing), planning a pregnancy or lactating.
- History of cancer that has not been in full remission for at least 3 years before screening.
- History of thyroid cancer.
- Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
- History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).
Show all 25Show fewer
- Severe gastroparesis within 6 months prior to screening.
- History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.
- Have a history of at least one episode of diabetic ketoacidosis (DKA) after receiving anti-diabetic medication.
- Fasting triglyceride level more than 750 mg/dL at screening.
- Serum calcitonin more than 50 picogram (pg/mL) at screening.
- Hemoglobinopathy that may affect determination of HbA1c.
- Uncontrolled hypertension at screening.
- Estimated Glomerular Filtration Rate (eGFR) less than 90 mL/minute/1.73 meter^2 (calculated using the Schwartz equation) at screening.
- ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.
- Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
- Current or previous insulin therapy used for more than 4 weeks (continuously) in the 3 months prior to screening.
- Use of a GLP-1receptor agonist at study entry and during the study.
- Any oral diabetic medications, except metformin, at study entry and during the study.
- Use of oral or systemically injected glucocorticoids is generally not allowed within the 3 months before randomization; however, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor.
- Weight loss medications.
- Antiretroviral drugs.
- Known allergy or serious hypersensitivity reaction to albiglutide or any product components (including yeast and human albumin), any other GLP 1 analogue, insulin, or other study medication's excipients or other contraindications.
- Any other reason the investigator deems the subject to be unsuitable for the study or may interfere with trial compliance (e.g. significant medical or psychiatric history).
- The subject has participated in a clinical trial and has received an investigational product or device within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Chicago, Illinois, 60634
GSK Investigational Site
El Paso, Texas, 79935
GSK Investigational Site
Morehead City, North Carolina, 28557
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients
The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will receive albiglutide). Approximately 210 eligible male and female subjects will be included in the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Albiglutide, Placebo
- Keywords
- GSK716155, Type 2 diabetes mellitus, albiglutide, safety, pediatric, efficacy
- 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.
AlbiglutideDrug
30 mg of lyophilized albiglutide will be delivered from a prefilled dual chamber glass cartridge (DCC). The pen injector system will deliver 0.5 mL albiglutide as a single subcutaneous injection once a week.
PlaceboDrug
Matching placebo will be delivered from a prefilled dual chamber glass cartridge DCC. The pen injector system will deliver 0.5 mL matching placebo as a single subcutaneous injection once a week.
| Study group | Role | What they receive |
|---|---|---|
| Albiglutide cohort 1: Part A | Experimental | Approximately 12 eligible subjects, aged between 14 to 18 years, will receive a single dose of 30 mg albiglutide post-randomization. Receives: Drug: Albiglutide |
| Placebo cohort 1: Part A | Placebo comparator | Approximately 3 eligible subjects, aged between 14 to 18 years, will receive a single dose of matching placebo post-randomization. Receives: Drug: Placebo |
| Albiglutide cohort 2: Part A | Experimental | Approximately 12 eligible subjects, aged between 10 to 14 years, will receive a single dose of 30 mg albiglutide post-randomization. Receives: Drug: Albiglutide |
| Placebo cohort 2: Part A | Placebo comparator | Approximately 3 eligible subjects, aged between 10 to 14 years, will receive a single dose of matching placebo post-randomization. Receives: Drug: Placebo |
| Albiglutide: Part B | Experimental | Approximately 120 eligible subjects, aged between 10 to 18 years, will receive albiglutide 30 mg once weekly post-randomization. Receives: Drug: Albiglutide |
| Placebo: Part B | Placebo comparator | Approximately 60 eligible subjects, aged between 10 to 18 years, will receive matching placebo once weekly post-randomization. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points
Measured: Up to 28 days post-dose
Maximum Plasma Concentration (Cmax) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Measured: Up to 28 days post-dose
Apparent clearance (CL/F) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Measured: Up to 28 days post-dose
Apparent volume of distribution (V/F) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Measured: Up to 28 days post-dose
Number of subjects with adverse events (AEs): Part A
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AESI including gastrointestinal events, hypoglycemia, injection site reactions, pancreatitis, medullary thyroid cancer, atrial fibrillation/flutter, and pneumonia etc will also be evaluated.
Measured: Up to Week 8 post dose
Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 24: Part B
Change in HbA1c values from Baseline will be evaluated at Week 24. The superiority of albiglutide over placebo will be assessed.
Measured: Up to Week 24
Time to reach maximum plasma concentration (tmax) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Measured: Up to 28 days post-dose
Time to reach half of the maximum plasma concentration (t1/2) of albiglutide: Part A
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Measured: Up to 28 days post-dose
Secondary outcomes (17)
Change from Baseline in fasting Plasma Glucose (FPG): Part B
FPG will be assessed as a measure of glycemic control.
Measured: Up to Week 24
Percentage of subjects reaching HbA1c less than 7%: Part B
Subjects reaching HbA1c less than 7% at the end of double-blind phase will be analyzed using logistic regression.
Measured: Up to Week 24
Time to hyperglycemia rescue: Part B
Time to hyperglycemia rescue will be measured at specific timeframe. Addition of or adjustment to metformin will be the first option for rescue therapy.
Measured: Up to Week 24
Number of subjects with AEs, serious adverse events (SAEs): Part B
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE. AESI including gastrointestinal events, hypoglycemia, injection site reactions, pancreatitis, medullary thyroid cancer, atrial fibrillation/flutter, and pneumonia etc will be evaluated.
Measured: Up to Week 60
Number of hypoglycemic episodes: Part B
Hypoglycaemic events as per American Diabetes Association (ADA) criteria: severe hypoglycaemia, documented symptomatic hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia and pseudo hypoglycaemia.
Measured: Up to Week 60
Evaluation of immunogenicity: Part B
Blood samples will be collected at intervals for the determination of anti-albiglutide antibodies.
Measured: Up to Week 60
Change from Baseline in serum calcitonin levels: Part B
Blood samples will be collected to measure serum calcitonin.
Measured: Up to Week 52
Number of subjects with abnormal clinical laboratory parameters: Part B
Hematological, clinical chemistry and urine parameters will be evaluated.
Measured: Up to Week 60
Assessment of Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP): Part B
SBP and DBP will be measured in a seated position after at least a 5-minute rest.
Measured: Up to Week 60
Assessment of pulse rate: Part B
Pulse rate will be measured in a seated position after at least a 5-minute rest.
Measured: Up to Week 60
Number of subjects with abnormal growth and development: Part B
Height, weight, tanner stage, menstrual history, sex hormones will be evaluated.
Measured: Up to Week 52
CL/F of albiglutide: Part B
Blood samples will be collected after repeat dose administration of study treatment at indicated time points
Measured: Up to Week 24
V/F of albiglutide: Part B
Blood samples will be collected after repeat dose administration of study treatment at indicated time points
Measured: Up to Week 24
First-order absorption rate constant(Ka): Part B
Blood samples will be collected after repeat dose administration of study treatment at indicated time points
Measured: Up to Week 24
Number of subjects showing covariate relationship between PK and clinical measure of interest: Part B
The relationship between albiglutide PK parameters and covariates will be evaluated graphically and in the population PK model.
Measured: Up to Week 24.
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) diabetes module total score: Part B
The diabetes module of the PedsQL is a disease specific instrument used to assess the degree of difficulty youth experience with different aspects of everyday living, including treatment adherence and barriers, diabetes-related worries, and communication with others about diabetes. Scores range from 0 to 100, with a higher PedsQL scores indicating better levels of functioning and quality of life (QOL).
Measured: Up to Week 52
Change from Baseline in Children's Depression Inventory 2 Self Report Short Version [CDI 2: SR(S)]
The CDI 2: SR(S) is a revision of the Children's Depression Inventory and is used to evaluate depressive symptoms in children and adolescents. The CDI 2: SR(S) Form contains 12 items and the domains include emotional problems and functional problems, with additional subscales of negative mood/physical symptoms, negative self-esteem, interpersonal problems and ineffectiveness.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start14 Aug 2017 (estimated)
- Primary completion20 Apr 2020 (estimated)
- Study completion20 Apr 2020 (estimated)
Why it stopped: The study did not start recruiting as albiglutide would have been withdrawn from the market prior to study end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015519
- Sponsor's protocol ID
- 200938
- Status last verified
- Jan 2019
- First submitted
- 14 Dec 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03015519
- Acronym / sponsor ID
- 200938
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GSK716155, Type 2 diabetes mellitus, albiglutide, safety, pediatric, efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start recruiting as albiglutide would have been withdrawn from the market prior to study end.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (estimated)
- Primary completion
- 20 Apr 2020 (estimated)
- Study completion
- 20 Apr 2020 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will receive albiglutide). Approximately 210 eligible male and female subjects will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Albiglutide cohort 1: Part A | Experimental | Drug: AlbiglutideApproximately 12 eligible subjects, aged between 14 to 18 years, will receive a single dose of 30 mg albiglutide post-randomization. |
| Placebo cohort 1: Part A | Placebo comparator | Drug: PlaceboApproximately 3 eligible subjects, aged between 14 to 18 years, will receive a single dose of matching placebo post-randomization. |
| Albiglutide cohort 2: Part A | Experimental | Drug: AlbiglutideApproximately 12 eligible subjects, aged between 10 to 14 years, will receive a single dose of 30 mg albiglutide post-randomization. |
| Placebo cohort 2: Part A | Placebo comparator | Drug: PlaceboApproximately 3 eligible subjects, aged between 10 to 14 years, will receive a single dose of matching placebo post-randomization. |
| Albiglutide: Part B | Experimental | Drug: AlbiglutideApproximately 120 eligible subjects, aged between 10 to 18 years, will receive albiglutide 30 mg once weekly post-randomization. |
| Placebo: Part B | Placebo comparator | Drug: PlaceboApproximately 60 eligible subjects, aged between 10 to 18 years, will receive matching placebo once weekly post-randomization. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Between 10 to less than 18 years of age inclusive at the time of screening.
- Diagnosis of T2DM with HbA1c more than or equal to 7.0% [53 millimole per mole (mmol/mol)] and less than 10.0% (85.8 mmol/mol) assessed at screening. Currently treated with regimen of diet and exercise with or without metformin. Subjects on metformin monotherapy should have been treated for a minimum of 8 weeks prior to randomization on a dose above 1000 milligram per day (mg/day) or prior documented maximum tolerated dose (MTD) less than or equal to 1000 mg/day.
- FPG less than 240 mg/deciliter (dL) at screening.
- Fasting C-peptide more than or equal to 0.8 nanogram per milliliter (ng/mL) at screening.
- Negative central laboratory assays for Glutamic Acid Decarboxylase 65 (GAD-65) and Islet Cell Autoantigen 512 (ICA512) autoantibodies at screening.
Key exclusion criteria (25 listed)
- Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
- Female subject is pregnant (confirmed by laboratory testing), planning a pregnancy or lactating.
- History of cancer that has not been in full remission for at least 3 years before screening.
- History of thyroid cancer.
- Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albiglutide30 mg of lyophilized albiglutide will be delivered from a prefilled dual chamber glass cartridge (DCC). The pen injector system will deliver 0.5 mL albiglutide as a single subcutaneous injection once a week. | Drug | Albiglutide cohort 1: Part A, Albiglutide cohort 2: Part A, Albiglutide: Part B |
| PlaceboMatching placebo will be delivered from a prefilled dual chamber glass cartridge DCC. The pen injector system will deliver 0.5 mL matching placebo as a single subcutaneous injection once a week. | Drug | Placebo cohort 1: Part A, Placebo cohort 2: Part A, Placebo: Part B |
Primary outcome
Area under the curve (AUC) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points
Maximum Plasma Concentration (Cmax) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Apparent clearance (CL/F) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Apparent volume of distribution (V/F) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Number of subjects with adverse events (AEs): Part A
Time frame: Up to Week 8 post dose
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AESI including gastrointestinal events, hypoglycemia, injection site reactions, pancreatitis, medullary thyroid cancer, atrial fibrillation/flutter, and pneumonia etc will also be evaluated.
Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 24: Part B
Time frame: Up to Week 24
Change in HbA1c values from Baseline will be evaluated at Week 24. The superiority of albiglutide over placebo will be assessed.
Time to reach maximum plasma concentration (tmax) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
Time to reach half of the maximum plasma concentration (t1/2) of albiglutide: Part A
Time frame: Up to 28 days post-dose
Blood samples will be collected prior to dosing at Baseline and following single-dose administration of albiglutide at indicated time points.
17 secondary outcomes
Change from Baseline in fasting Plasma Glucose (FPG): Part B
Time frame: Up to Week 24
Percentage of subjects reaching HbA1c less than 7%: Part B
Time frame: Up to Week 24
Time to hyperglycemia rescue: Part B
Time frame: Up to Week 24
Number of subjects with AEs, serious adverse events (SAEs): Part B
Time frame: Up to Week 60
Number of hypoglycemic episodes: Part B
Time frame: Up to Week 60
Evaluation of immunogenicity: Part B
Time frame: Up to Week 60
Change from Baseline in serum calcitonin levels: Part B
Time frame: Up to Week 52
Number of subjects with abnormal clinical laboratory parameters: Part B
Time frame: Up to Week 60
Assessment of Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP): Part B
Time frame: Up to Week 60
Assessment of pulse rate: Part B
Time frame: Up to Week 60
Number of subjects with abnormal growth and development: Part B
Time frame: Up to Week 52
CL/F of albiglutide: Part B
Time frame: Up to Week 24
V/F of albiglutide: Part B
Time frame: Up to Week 24
First-order absorption rate constant(Ka): Part B
Time frame: Up to Week 24
Number of subjects showing covariate relationship between PK and clinical measure of interest: Part B
Time frame: Up to Week 24.
Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) diabetes module total score: Part B
Time frame: Up to Week 52
Change from Baseline in Children's Depression Inventory 2 Self Report Short Version [CDI 2: SR(S)]
Time frame: Up to Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 3 sites in United States.
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 8 inclusion and 25 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: withdrawn, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Area under the curve (AUC) of albiglutide: Part A (time frame: Up to 28 days post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2019.