A Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Oral Monotherapy Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777282
• Other study ID #: 116170
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2013
• Last updated: January 25, 2016
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.

Description:

This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects with diagnosis of Type 2 Diabetes Mellitus, who are experiencing inadequate glycemic control and receiving treatment with a stable dose of a single oral antidiabetic medication

• Body mass index (BMI) 17 to 40 kg/ m2 inclusive

• Subjects with an HbA1c between 7.0% and 10.0% at Screening

• Creatinine clearance >30 mL/min (calculated using the Cockcroft-Gault formula)

Exclusion Criteria:

• History of type 1 diabetes mellitus

• Female subject is pregnant, lactating, or <6 weeks postpartum

• Clinically significant cardiovascular and/or cerebrovascular disease

• Current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator

• Serum amylase >=3 ×ULN and/or serum lipase >=2 × ULN and/or subject is experiencing any symptoms possibly related to pancreatitis

• Prior use of a GLP-1R agonist or DPP-IV inhibitor within 6 months before Screening

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Albiglutide
Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
• Sulfonylurea
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
• Biguanide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
• Glinide
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
• Thiazolidinedione
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
• Alpha-glucosidase inhibitor
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Ehime
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukushima
Japan	GSK Investigational Site	Fukushima
Japan	GSK Investigational Site	Gunma
Japan	GSK Investigational Site	Gunma
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kochi
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Oita
Japan	GSK Investigational Site	Okinawa
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Shizuoka
Japan	GSK Investigational Site	Tochigi
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)	An AE is defined as any untoward medical occurrence in a clinical investigation participant, 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.	From Baseline through Week 52	No
Primary	Number of Participants With Any Hypoglycemic Event	Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.	From Baseline through Week 52	No
Secondary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.	Baseline and Week 52	No
Secondary	Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.	Week 52	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.	Baseline and Week 52	No
Secondary	Change From Baseline in Body Weight at Week 52	The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.	Baseline and Week 52	No
Secondary	Time to Study Withdrawal Due to Hyperglycemia	Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to	Week 52	No