Clinical trial NCT00976391: A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
Official title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: open-label
albiglutide
insulin glargine
preprandial insulin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

Detailed description: This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for \>/= 6 months but \< 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of \< 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.

Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes, currently treated with insulin glargine or other intermediate- or long-acting insulin, with or without oral antidiabetic medications, but experiencing inadequate glycemic control and willing and capable of participating in a regimen of intensive insulin administration. A subject who has been on an intermediate- or long acting insulin for \>/=6 months but \<5 years, and, in spite of dosage adjustments based on home blood glucose monitoring, is unable to achieve a HbA1c of \<7%.
* BMI \>/= 20kg/m2 and \</=45 kg/m2
* Fasting C-peptide \>/=0.8 ng/mL (\>/= 0.26 nmol/L)
* HbA1c between 7.0% and 10.5%, inclusive
* Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed
* Hemoglobin \</=11 g/dL for male subjects and \>/=10 g/dL for female subjects
* Creatinine clearance \>60 mL/min (calculated using the Cockcroft Gault formula)
* Thyroid stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin)
* Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study including the 8 week Posttreatment Follow-up Period
* Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor as per the protocol recommendations of self administration
* No major illness or debility that in the investigator's opinion prohibits the subject from actively participating in their diabetes management and completing the study
* Able and willing to provide written informed consent

Exclusion Criteria:

* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening.
* History of treated diabetic gastroparesis
* Current ongoing symptomatic biliary disease or history of pancreatitis
* History of significant gastrointestinal surgery, including gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function
* Recent clinically significant cardiovascular and/or cerebrovascular disease including but not limited to the following:

  * Previous history of stroke or transient ischemic attack within 1 month before Screening.
  * Acute coronary syndrome, which includes the following:
  * Documented MI within the 2 months before Screening and during the period up until receiving the first dose of study medication
  * Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within the 2 months before Screening and during the period up until receiving the first dose of study medication
  * Unstable angina not responsive to nitroglycerin within the 2 months before Screening and during the period up until receiving the first dose of study medication
  * Unstable cardiac rhythm, however, as an example, controlled atrial fibrillation is allowed
  * Current or history of heart failure (New York Heart Association class I to IV).
  * Resting systolic pressure is \>160 mm Hg and/or diastolic pressure \>100 mm Hg.
  * QTc interval (Fridericia) \>470 ms confirmed by a central reader at Screening
* History of stroke or other central nervous system disorder that would negatively impact the subject's ability to participate in a program of intensive insulin management (eg, physically or mentally incapable of performing home blood glucose monitoring or administering and/or adjusting insulin dosage)
* Hemoglobinopathy that may affect determination of HbA1c
* History of human immunodeficiency virus infection
* History of total bilirubin \>1.5 × ULN unless the subject has a previously known history of Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \<35% of total bilirubin
* ALT or aspartate aminotransferase (AST) \>2.5 ×ULN
* Fasting triglyceride level \>850 mg/dL at Screening or Week -1 (Visit 5).
* Acute symptomatic (within 3 months before Screening) infection with hepatitis B or hepatitis C; however, subjects with past or chronic hepatitis B or hepatitis C are allowed provided the requirements for ALT, AST, and total bilirubin are met
* History of a psychiatric disorder that will affect the subject's ability to participate in the study
* History of alcohol or substance abuse within 1 year before Screening
* Positive urine drug screen at Screening, unless the subject is taking a medically approved medication for which a positive drug screen simply verifies the use of this medication
* Hypoglycemia unawareness which has impaired cognitive function and required outside assistance
* Female subject is pregnant (confirmed by laboratory testing), lactating, or \<6 weeks postpartum
* Known allergy to any GLP 1 analogue, insulin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
* Receipt of any investigational drug within the 30 days, or 5 half lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies
* Current use of any GLP 1 analogue
* History of type 1 diabetes mellitus, diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) that in the opinion of the investigator would preclude effective participation in the study, or a history of ketoacidosis or hyperosmolar coma
* Contraindications (as per the prescribing information) for the use of either background or potential randomized study medications (e.g., insulin glargine or lispro insulin)
* History or family history of medullary carcinoma
* History or family history of multiple endocrine neoplasia type 2

Primary outcomes:
measure: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c at Weeks 36, 48 and 52
timeFrame: Baseline and Weeks 36, 48 and 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52
timeFrame: Baseline and Weeks 36, 48 and 52
measure: Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26
timeFrame: Week 26
measure: Time to Hyperglycemia Rescue
timeFrame: From the start of study medication until the end of the treatment (up to Week 52)
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Body Weight at Weeks 36, 48 and 52
timeFrame: Baseline and Weeks 36, 48 and 52
Other outcomes:
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city: Haverhill
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city: Bloomfield Hills
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city: Picayune
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city: Jefferson City
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city: Kansas City
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city: St. Louis
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city: Great Falls
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city: Omaha
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city: Omaha
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city: Haddon Heights
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city: North Massapequa
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city: Asheville
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state: North Carolina
city: Burlington
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city: Durham
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state: North Carolina
city: Hickory
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city: Morehead City
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city: Bedford
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city: Dallas
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state: Texas
city: Dallas
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state: Texas
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state: Texas
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state: Texas
city: Houston
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state: Texas
city: Houston
country: United States
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state: Texas
city: Katy
country: United States
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state: Texas
city: Lake Jackson
country: United States
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state: Texas
city: Midland
country: United States
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state: Texas
city: North Richland Hills
country: United States
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state: Texas
city: San Antonio
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Schertz
country: United States
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city: Sugar Land
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state: Texas
city: Temple
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city: Bountiful
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state: Utah
city: Salt Lake City
country: United States
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city: Salt Lake City
country: United States
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state: Utah
city: South Burlington
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city: Burke
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state: Virginia
city: Richmond
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state: Virginia
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country: United States
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state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Lewisburg
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Brasília
country: Brazil
facility: GSK Investigational Site
city: Mogi das Cruzes
country: Brazil
facility: GSK Investigational Site
city: Armentières
country: France
facility: GSK Investigational Site
city: Venissieux
country: France
facility: GSK Investigational Site
city: Witten
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Manipal
country: India
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Koyang-shi
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si,
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Kyonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Puebla
country: Mexico
facility: GSK Investigational Site
city: Huacho
country: Peru
facility: GSK Investigational Site
state: Lima
city: Ica
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Piura
country: Peru
facility: GSK Investigational Site
city: Trujillo
country: Peru
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city: Marikina City
country: Philippines
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city: Pasay
country: Philippines
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city: Pasig
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
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city: San Juan
country: Philippines
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city: Tagbilaran City
country: Philippines
facility: GSK Investigational Site
city: Taytay Rizal
country: Philippines
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Boksburg North
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Durban
country: South Africa
facility: GSK Investigational Site
state: KwaZulu- Natal
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Parow
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Alzira
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Sabadell
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei County
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Plymouth
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.