Diabetes Mellitus, Type 2Phase 3NCT02229240
Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing Albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
Trial summary
This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter, treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy (with or without metformin) in subjects… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- No sites listed yet
- Study dates
- Aug 2015to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
- HbA1c >=7.5% and <=10.0% at Screening.
- Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following: Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro); In addition, the total daily dose of insulin must be <=150 units; If taking metformin, a stable dose for at least 8 weeks before Screening. Note: Subject should not have received any other antidiabetic medication within 30 days before Screening (e.g., glucagon-like peptide-1 receptor [GLP-1R] agonist, dipeptidyl peptidase-IV inhibitor, sulfonylurea, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.
- Body mass index <=40 kilogram (kg) per squaremeter (m^2)
- Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4 )
- Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week Posttreatment Follow-up Period.
- Willing and able to comply with all study procedures including intensive insulin administration and performance of frequent SMBG profiles according to the protocol
- Able and willing to provide written informed consent
Who cannot join
- Type 1 diabetes mellitus
- History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Current symptomatic biliary disease or history of acute or chronic pancreatitis
- Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening
- History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function (e.g., gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function)
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- History of severe hypoglycemia unawareness
- Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product
- Clinically significant cardiovascular and/or cerebrovascular disease within 3 months before Screening including, but not limited to, the following: Stroke or transient ischemic attack; Acute coronary syndrome (myocardial infarction [MI] or unstable angina not responsive to nitroglycerin); Cardiac surgery or percutaneous coronary procedure; Current or history of heart failure (New York Heart Association class III or IV)
- Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment [e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening])
- Hemoglobin <11 g/dL (<110 gram per liter [g/L]) for male subjects and <10 g/dL (<100 g/L) for female subjects at Screening
- Estimated glomerular filtration rate (eGFR) <=30 mL/minute/1.73 m^2 (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at Screening. Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.
- Fasting triglyceride level >750 mg/dL at Screening
- Hemoglobinopathy that may affect proper interpretation of HbA1c
- Known allergy 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 (per the prescribing information) for the use of potential study medications (e.g., basal-bolus insulin)
- Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following 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. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
- Female subject is pregnant (confirmed by laboratory testing) or lactating
- Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies
- Subject that, in the opinion of the investigator, will not benefit from participating in a treat to target study aimed at achieving HbA1c of 7.0%
About this study
Official title: Study GLP111892: Albiglutide Versus Placebo as Add-on to Intensified Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter, treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy (with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + intensified basal-bolus insulin therapy (with or without metformin) or placebo + intensified basal-bolus insulin therapy (with or without metformin. The total duration of a subject's participation will be approximately 32 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Albiglutide, Matching albiglutide placebo
- Keywords
- Albiglutide, Add-on to basal-bolus insulin therapy, Glucagon-like peptide-1 receptor agonist, Type 2 diabetes mellitus
- 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
Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector
Matching albiglutide placeboDrug
Matching albiglutide placebo will be provided as 0.5-mL injection, fully disposable pen injector system
| Study group | Role | What they receive |
|---|---|---|
| Albiglutide | Experimental | Subjects will receive once-weekly subcutaneous injections of albiglutide 30 mg (with forced uptitration to albiglutide 50 mg at Week 4) in addition to intensification of background basal-bolus insulin therapy (with or without metformin) according to predefined titration algorithms. Receives: Drug: Albiglutide |
| Matching albiglutide placebo | Placebo comparator | Subjects will receive once-weekly subcutaneous injections of matching albiglutide placebo in addition to intensification of background basal-bolus insulin therapy (with or without metformin) according to predefined titration algorithms Receives: Drug: Matching albiglutide placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with severe or documented symptomatic hypoglycemia through Week 26
Severe hypoglycemia is defined as requiring third-party intervention. Documented symptomatic hypoglycaemia is defined as typical symptoms of hypoglycemia with an accompanying plasma glucose concentration <=70 milligram (mg) per decilitre (dL) (<=3.9 millimole per liter [mmol/L]).
Measured: Up to Week 26
Change from baseline in glycosylated hemoglobin (HbA1c) at Week 26
Measured: Week 26
Secondary outcomes (11)
Change from baseline in body weight at Week 26 and over time
Measured: Up to Week 26
Total daily insulin dose, basal insulin dose and bolus insulin dose at Week 26 and over time
Measured: Up to Week 26
HbA1c change from baseline in over time
Measured: Up to Week 26
Fasting plasma glucose (FPG) change from Baseline at Week 26 and over time
Measured: Up to Week 26
Proportion of subjects achieving a HbA1c <7.0% and < 6.5% at Week 26 and over time
Measured: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without weight gain after 26 weeks of treatment
Measured: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia after 26 weeks of treatment
Measured: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia after 26 weeks of treatment
Measured: Up to Week 26
Number of subjects with non-serious adverse events (AE), serious adverse events (SAE), and AEs and SAEs leading to discontinuation
Measured: Up to Week 30
Incidence of hypoglycemic events
Measured: Up to Week 30
Assessment of clinical laboratory tests, lipids, vital signs, ECGs and physical examinations
Measured: Up to Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Study was cancelled prior to enrolling any patients
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)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229240
- Sponsor's protocol ID
- 111892
- Status last verified
- Jan 2016
- First submitted
- 28 Aug 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study GLP111892: Albiglutide Versus Placebo as Add-on to Intensified Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02229240
- Acronym / sponsor ID
- 111892
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Albiglutide, Add-on to basal-bolus insulin therapy, Glucagon-like peptide-1 receptor agonist, Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled prior to enrolling any patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Sep 2014 (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.
This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter, treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy (with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + intensified basal-bolus insulin therapy (with or without metformin) or placebo + intensified basal-bolus insulin therapy (with or without metformin. The total duration of a subject's participation will be approximately 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albiglutide | Experimental | Drug: AlbiglutideSubjects will receive once-weekly subcutaneous injections of albiglutide 30 mg (with forced uptitration to albiglutide 50 mg at Week 4) in addition to intensification of background basal-bolus insulin therapy (with or without metformin) according to predefined titration algorithms. |
| Matching albiglutide placebo | Placebo comparator | Drug: Matching albiglutide placeboSubjects will receive once-weekly subcutaneous injections of matching albiglutide placebo in addition to intensification of background basal-bolus insulin therapy (with or without metformin) according to predefined titration algorithms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
- HbA1c >=7.5% and <=10.0% at Screening.
- Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following: Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro); In addition, the total daily dose of insulin must be <=150 units; If taking metformin, a stable dose for at least 8 weeks before Screening. Note: Subject should not have received any other antidiabetic medication within 30 days before Screening (e.g., glucagon-like peptide-1 receptor [GLP-1R] agonist, dipeptidyl peptidase-IV inhibitor, sulfonylurea, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.
- Body mass index <=40 kilogram (kg) per squaremeter (m^2)
- Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4 )
Key exclusion criteria (20 listed)
- Type 1 diabetes mellitus
- History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Current symptomatic biliary disease or history of acute or chronic pancreatitis
- Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening
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 |
|---|---|---|
| AlbiglutideAlbiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector | Drug | Albiglutide |
| Matching albiglutide placeboMatching albiglutide placebo will be provided as 0.5-mL injection, fully disposable pen injector system | Drug | Matching albiglutide placebo |
Primary outcome
Percentage of subjects with severe or documented symptomatic hypoglycemia through Week 26
Time frame: Up to Week 26
Severe hypoglycemia is defined as requiring third-party intervention. Documented symptomatic hypoglycaemia is defined as typical symptoms of hypoglycemia with an accompanying plasma glucose concentration <=70 milligram (mg) per decilitre (dL) (<=3.9 millimole per liter [mmol/L]).
Change from baseline in glycosylated hemoglobin (HbA1c) at Week 26
Time frame: Week 26
11 secondary outcomes
Change from baseline in body weight at Week 26 and over time
Time frame: Up to Week 26
Total daily insulin dose, basal insulin dose and bolus insulin dose at Week 26 and over time
Time frame: Up to Week 26
HbA1c change from baseline in over time
Time frame: Up to Week 26
Fasting plasma glucose (FPG) change from Baseline at Week 26 and over time
Time frame: Up to Week 26
Proportion of subjects achieving a HbA1c <7.0% and < 6.5% at Week 26 and over time
Time frame: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without weight gain after 26 weeks of treatment
Time frame: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia after 26 weeks of treatment
Time frame: Up to Week 26
Percentage of subjects achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia after 26 weeks of treatment
Time frame: Up to Week 26
Number of subjects with non-serious adverse events (AE), serious adverse events (SAE), and AEs and SAEs leading to discontinuation
Time frame: Up to Week 30
Incidence of hypoglycemic events
Time frame: Up to Week 30
Assessment of clinical laboratory tests, lipids, vital signs, ECGs and physical examinations
Time frame: Up to Week 30
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 11 Jan 2016.
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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
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.
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 20 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 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of subjects with severe or documented symptomatic hypoglycemia through Week 26 (time frame: Up to Week 26). 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?
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 11 Jan 2016.