Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:7/1/2018
Start Date:November 21, 2014
End Date:July 24, 2017

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Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat
to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of
once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes
mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus
insulin regimen (with or without metformin). Approximately 794 subjects will be randomly
assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with
insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification
of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4
study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and
Post treatment Follow up (4 weeks). The total duration of a subject's participation will be
approximately 36 weeks.


Inclusion Criteria:

- Male or female, 18 years of age or older (inclusive at the time of Screening) with
T2DM

- HbA1c >= 7.0% and <= 9.0% 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) with a total daily dose of bolus insulin <= 70 units

- In addition, the total daily dose of insulin must be <= 140 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, SU, or thiazolidinedione). Subjects receiving commercially
available premixed basal and prandial insulin are not eligible for this study.

- Fasting C-peptide >= 0.8 nanogram (ng) per milliliter (mL) [>= 0.26 nanomoles per
litre (nmol/L)]

- Body mass index <= 40 kilogram per square meter( kg/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 post treatment
Follow-up Period..

- Willing and able to comply with all study procedures including performance of frequent
self-monitored blood glucose (SMBG) profiles according to the protocol

- Able and willing to provide written informed consent

Exclusion Criteria:

- 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]

- 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 CV 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 gram (g) per (dL) [<110 g/L] for male subjects and <10 g/dL (<100 g/L)
for female subjects at Screening

- Estimated glomerular filtration rate (eGFR) <= 30 millilitre per minute per 1.73
square meters (mL/min/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., insulin glargine, insulin lispro)

- 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
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